The document provides an overview of the US Food and Drug Administration (FDA). It details that the FDA was formed in 1906 and regulates food, drugs, medical devices, tobacco and more. It protects public health by ensuring these products are safe and properly labeled. The FDA is part of the Department of Health and Human Services and has over 11,500 employees across the US and foreign offices. It has an annual budget of $2.3 billion.
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
73What is Special Education 1iStockphotoThinkstock.docxalinainglis
73
What is Special Education? 1
iStockphoto/Thinkstock
Pre-Test
1. You can use the terms disability and handicap interchangeably. T/F
2. The history of special education began in Europe. T/F
3. The first American legislation that protected students with disabilities was passed in the 1950s. T/F
4. All students with disabilities should be educated in special education classrooms. T/F
5. Special education law is constantly reinterpreted. T/F
Answers can be found at the end of the chapter.
4Accreditation, Regulation, and
Agencies of Healthcare Quality
Alex Brandon/AP/Associated Press
Learning Objectives
After reading this chapter, you should be able to do the following:
• Illustrate how healthcare policies, rules and regulations, and guidelines impact quality of care.
• Analyze the role of accreditors, including The Joint Commission, along with major steps in the
accreditation of healthcare organizations.
• Evaluate the role of Leapfrog group on quality of healthcare and the methodology used to compute
the hospital safety score.
• Analyze the structure and process of the National Committee for Quality Assurance (NCQA)
accreditation for health plans.
• Assess the role of several government institutions on the quality of care.
fin81226_04_c04_073-118.indd 73 10/30/14 7:41 PM
Introduction
Introduction
At the turn of the 20th century, there were few federal regulations to protect the public from
dangerous drugs. Many harmful products were freely sold, such as William Radam’s Microbe
Killer and Benjamin Bye’s Soothing Balmy Oils to cure cancer. As is sometimes the case, trag-
edy brought about the first real regulation to protect consumers health and safety. The Bio-
logics Control Act was passed in 1902 after two incidents involving the deaths of children
caused by contaminated vaccines. The law mandated producers in the U.S. to be licensed each
year for the manufacture and sale of biologics such as antitoxins, serum, and vaccines to pre-
vent future tragedies from reoccurring. That was followed by the Pure Food and Drugs Act in
1906, which prohibited interstate commerce in misbranded and adulterated foods, drinks,
and drugs and mandated strict health safety and testing policies. The law was passed mainly
in response to shocking public disclosures of unsanitary conditions in meat packing plants, as
well as fears over poisonous preservatives and dyes in foods.
However, the 1906 law had its shortcomings and the government’s hands were tied when it
came to preventing the sale of medicinal products that carried wild claims of health cures.
In 1910, the government stopped sales of a product called Dr. Johnson’s Mild Combination
Treatment for Cancer, but the Supreme Court ruled in favor of the company because the prod-
uct’s false claims were not within the scope of the Pure Food and Drugs Act (Meadows, 2006).
As a result, in 1912, Congress passed the Sherley Amendment, which prohibited labels on
medicines that fals.
Analyzing the Dietary Supplement Health and Education Act and other related r...AJHSSR Journal
The research introduces the policy of Dietary Supplement Health and Education Act (DSHEA) and relevant regulations and backgrounds with quantitative data analysis. Studying case studies of Dietary Supplement Health Educational Act (DSHEA) might address Food and Drug Administration (FDA) accountabilities and improvements.
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
73What is Special Education 1iStockphotoThinkstock.docxalinainglis
73
What is Special Education? 1
iStockphoto/Thinkstock
Pre-Test
1. You can use the terms disability and handicap interchangeably. T/F
2. The history of special education began in Europe. T/F
3. The first American legislation that protected students with disabilities was passed in the 1950s. T/F
4. All students with disabilities should be educated in special education classrooms. T/F
5. Special education law is constantly reinterpreted. T/F
Answers can be found at the end of the chapter.
4Accreditation, Regulation, and
Agencies of Healthcare Quality
Alex Brandon/AP/Associated Press
Learning Objectives
After reading this chapter, you should be able to do the following:
• Illustrate how healthcare policies, rules and regulations, and guidelines impact quality of care.
• Analyze the role of accreditors, including The Joint Commission, along with major steps in the
accreditation of healthcare organizations.
• Evaluate the role of Leapfrog group on quality of healthcare and the methodology used to compute
the hospital safety score.
• Analyze the structure and process of the National Committee for Quality Assurance (NCQA)
accreditation for health plans.
• Assess the role of several government institutions on the quality of care.
fin81226_04_c04_073-118.indd 73 10/30/14 7:41 PM
Introduction
Introduction
At the turn of the 20th century, there were few federal regulations to protect the public from
dangerous drugs. Many harmful products were freely sold, such as William Radam’s Microbe
Killer and Benjamin Bye’s Soothing Balmy Oils to cure cancer. As is sometimes the case, trag-
edy brought about the first real regulation to protect consumers health and safety. The Bio-
logics Control Act was passed in 1902 after two incidents involving the deaths of children
caused by contaminated vaccines. The law mandated producers in the U.S. to be licensed each
year for the manufacture and sale of biologics such as antitoxins, serum, and vaccines to pre-
vent future tragedies from reoccurring. That was followed by the Pure Food and Drugs Act in
1906, which prohibited interstate commerce in misbranded and adulterated foods, drinks,
and drugs and mandated strict health safety and testing policies. The law was passed mainly
in response to shocking public disclosures of unsanitary conditions in meat packing plants, as
well as fears over poisonous preservatives and dyes in foods.
However, the 1906 law had its shortcomings and the government’s hands were tied when it
came to preventing the sale of medicinal products that carried wild claims of health cures.
In 1910, the government stopped sales of a product called Dr. Johnson’s Mild Combination
Treatment for Cancer, but the Supreme Court ruled in favor of the company because the prod-
uct’s false claims were not within the scope of the Pure Food and Drugs Act (Meadows, 2006).
As a result, in 1912, Congress passed the Sherley Amendment, which prohibited labels on
medicines that fals.
Analyzing the Dietary Supplement Health and Education Act and other related r...AJHSSR Journal
The research introduces the policy of Dietary Supplement Health and Education Act (DSHEA) and relevant regulations and backgrounds with quantitative data analysis. Studying case studies of Dietary Supplement Health Educational Act (DSHEA) might address Food and Drug Administration (FDA) accountabilities and improvements.
CHAPTER 23 Consumer ProtectionRestaurantFederal and state go.docxtiffanyd4
CHAPTER 23 Consumer Protection
Restaurant
Federal and state governments have enacted many statutes to protect consumers from unsafe food items.
Learning Objectives
After studying this chapter, you should be able to:
1. Describe government regulation of food and food additives.
2. Describe government regulation of drugs, cosmetics, and medicinal devices.
3. Identify and describe unfair and deceptive business practices.
4. Describe the United Nations Biosafety Protocol concerning genetically altered foods.
5. List and describe consumer financial protection laws.
Chapter Outline
1. Introduction to Consumer Protection
2. Food Safety
1. Case 23.1 • United States of America v. LaGrou Distribution Systems, Incorporated
3. Food, Drugs, and Cosmetics Safety
1. LANDMARK LAW • Food, Drug, and Cosmetic Act
2. ETHICS • Restaurants Required to Disclose Calories of Food Items
3. GLOBAL LAW • United Nations Biosafety Protocol for Genetically Altered Foods
4. Product and Automobile Safety
5. Medical and Health Care Protection
1. LANDMARK LAW • Health Care Reform Act of 2010
6. Unfair and Deceptive Practices
1. CONTEMPORARY ENVIRONMENT • Do-Not-Call Registry
7. Consumer Financial Protection
1. CONTEMPORARY ENVIRONMENT • Consumer Financial Protection Bureau
2. ETHICS • Credit CARD Act
3. BUSINESS ENVIRONMENT • Dodd-Frank Wall Street Reform and Consumer Protection Act
“ I should regret to find that the law was powerless to enforce the most elementary principles of commercial morality.”
—Lord Herschell Reddaway v. Banham (1896)
Introduction to Consumer Protection and Product Safety
Originally, sales transactions in this country were guided by the principle of caveat emptor(“let the buyer beware”). This led to abusive practices by businesses that sold adulterated food products and other unsafe products. In response, federal and state governments have enacted a variety of statutes that regulate the safety of food, drugs, cosmetics, toys, vehicles, and other products. In addition, governments have enacted consumer financial protection laws that protect consumer-debtors in credit transactions. These laws are collectively referred to as consumer protection laws .
consumer protection laws
Federal and state statutes and regulations that promote product safety and prohibit abusive, unfair, and deceptive business practices.
This chapter covers consumer protection and product safety laws.
Food Safety
The safety of food is an important concern in the United States and worldwide. In the United States, the U.S. Department of Agriculture (USDA) is the federal administrative agency that is responsible primarily for regulating meat, poultry, and other food products. The USDA conducts inspections of food-processing and storage facilities. The USDA can initiate legal proceedings against violators.
U.S. Department of Agriculture (USDA)
A federal administrative agency that is responsible for regulating the safety of meat, poultry, and other food products.
The following case involve.
IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
http://www.bizsum.com/summaries/inside-fda
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
History of regulatory affair. Various Regulatory Authority. Role of Regulatory Affairs Department.
Pre-clinical or Non- clinical phase of drug development . Investigational New Drug Application (IND) Importance of IND. Investigator’s Brochure (IB). The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. A complete and thorough investigator’s brochure should include the following: Title Page
I. A] Confidentiality Statement
II. Contents of the Investigator’s Brochure
II. A] Table of Contents
II. B] Summary
II. C] Introduction
II. D] Physical, Chemical, and Pharmaceutical Properties and
Formulation
II. E] Nonclinical Studies
II. F] Effects in Humans
II. G] Summary of Data and Guidance for the Investigator. Contents of the Investigator’s Brochure: II. A] Table of Contents
II. B] Summary:
Not longer than 2 pages.
Highlighting significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic and clinical information available that is relevant to the state of clinical development of the investigational product. II. D] Physical, Chemical, and Pharmaceutical Properties
and Formulation:
A description of the investigational product substances including the chemical and or structural formulae and the brief summary of the relevant physical, chemical and pharmaceutical properties.
For safety measures, a description of the formulations to be used including excipients (a substance formulated with the active ingredient of a medication) should be provided and justified if clinically relevant.
Instructions for the storage and handling of the dosage should be provided.
Structural similarities to other known compounds should be mentioned. Pharmacokinetics and Product Metabolism in Humans
A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the following, if available:
Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution and elimination).
Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference dosage form.
Population subgroups (e.g. gender, age, and impaired organ function).
Interactions (e.g. product-product interactions and effects of food).
Other pharmacokinetic data (e.g. results of population studies performed within clinical trial(s). . Marketing Experience
The Investigator’s Brochure should identify countries where the investigational product has been approved.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
CHAPTER 23 Consumer ProtectionRestaurantFederal and state go.docxtiffanyd4
CHAPTER 23 Consumer Protection
Restaurant
Federal and state governments have enacted many statutes to protect consumers from unsafe food items.
Learning Objectives
After studying this chapter, you should be able to:
1. Describe government regulation of food and food additives.
2. Describe government regulation of drugs, cosmetics, and medicinal devices.
3. Identify and describe unfair and deceptive business practices.
4. Describe the United Nations Biosafety Protocol concerning genetically altered foods.
5. List and describe consumer financial protection laws.
Chapter Outline
1. Introduction to Consumer Protection
2. Food Safety
1. Case 23.1 • United States of America v. LaGrou Distribution Systems, Incorporated
3. Food, Drugs, and Cosmetics Safety
1. LANDMARK LAW • Food, Drug, and Cosmetic Act
2. ETHICS • Restaurants Required to Disclose Calories of Food Items
3. GLOBAL LAW • United Nations Biosafety Protocol for Genetically Altered Foods
4. Product and Automobile Safety
5. Medical and Health Care Protection
1. LANDMARK LAW • Health Care Reform Act of 2010
6. Unfair and Deceptive Practices
1. CONTEMPORARY ENVIRONMENT • Do-Not-Call Registry
7. Consumer Financial Protection
1. CONTEMPORARY ENVIRONMENT • Consumer Financial Protection Bureau
2. ETHICS • Credit CARD Act
3. BUSINESS ENVIRONMENT • Dodd-Frank Wall Street Reform and Consumer Protection Act
“ I should regret to find that the law was powerless to enforce the most elementary principles of commercial morality.”
—Lord Herschell Reddaway v. Banham (1896)
Introduction to Consumer Protection and Product Safety
Originally, sales transactions in this country were guided by the principle of caveat emptor(“let the buyer beware”). This led to abusive practices by businesses that sold adulterated food products and other unsafe products. In response, federal and state governments have enacted a variety of statutes that regulate the safety of food, drugs, cosmetics, toys, vehicles, and other products. In addition, governments have enacted consumer financial protection laws that protect consumer-debtors in credit transactions. These laws are collectively referred to as consumer protection laws .
consumer protection laws
Federal and state statutes and regulations that promote product safety and prohibit abusive, unfair, and deceptive business practices.
This chapter covers consumer protection and product safety laws.
Food Safety
The safety of food is an important concern in the United States and worldwide. In the United States, the U.S. Department of Agriculture (USDA) is the federal administrative agency that is responsible primarily for regulating meat, poultry, and other food products. The USDA conducts inspections of food-processing and storage facilities. The USDA can initiate legal proceedings against violators.
U.S. Department of Agriculture (USDA)
A federal administrative agency that is responsible for regulating the safety of meat, poultry, and other food products.
The following case involve.
IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
http://www.bizsum.com/summaries/inside-fda
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
History of regulatory affair. Various Regulatory Authority. Role of Regulatory Affairs Department.
Pre-clinical or Non- clinical phase of drug development . Investigational New Drug Application (IND) Importance of IND. Investigator’s Brochure (IB). The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. A complete and thorough investigator’s brochure should include the following: Title Page
I. A] Confidentiality Statement
II. Contents of the Investigator’s Brochure
II. A] Table of Contents
II. B] Summary
II. C] Introduction
II. D] Physical, Chemical, and Pharmaceutical Properties and
Formulation
II. E] Nonclinical Studies
II. F] Effects in Humans
II. G] Summary of Data and Guidance for the Investigator. Contents of the Investigator’s Brochure: II. A] Table of Contents
II. B] Summary:
Not longer than 2 pages.
Highlighting significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic and clinical information available that is relevant to the state of clinical development of the investigational product. II. D] Physical, Chemical, and Pharmaceutical Properties
and Formulation:
A description of the investigational product substances including the chemical and or structural formulae and the brief summary of the relevant physical, chemical and pharmaceutical properties.
For safety measures, a description of the formulations to be used including excipients (a substance formulated with the active ingredient of a medication) should be provided and justified if clinically relevant.
Instructions for the storage and handling of the dosage should be provided.
Structural similarities to other known compounds should be mentioned. Pharmacokinetics and Product Metabolism in Humans
A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the following, if available:
Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution and elimination).
Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference dosage form.
Population subgroups (e.g. gender, age, and impaired organ function).
Interactions (e.g. product-product interactions and effects of food).
Other pharmacokinetic data (e.g. results of population studies performed within clinical trial(s). . Marketing Experience
The Investigator’s Brochure should identify countries where the investigational product has been approved.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
Explore our infographic on 'Essential Metrics for Palliative Care Management' which highlights key performance indicators crucial for enhancing the quality and efficiency of palliative care services.
This visual guide breaks down important metrics across four categories: Patient-Centered Metrics, Care Efficiency Metrics, Quality of Life Metrics, and Staff Metrics. Each section is designed to help healthcare professionals monitor and improve care delivery for patients facing serious illnesses. Understand how to implement these metrics in your palliative care practices for better outcomes and higher satisfaction levels.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
2. Content
2
Introduction
History
Responsibility of USFDA
Organization
Constitution
FDAAdvisory committee
Scope and Fundings
Legal Authority of FDA
Mission
What USFDA regulates?
What USFDA does not regulates?
Recent Update
References
04/28/16
Sagar Kishor Savale
3. FDA Logo
Agency overview
Formed 1906
Preceding agencies Food, Drug, and InsecticideAdministration (July 1927 to July 1930)
Bureau of Chemistry (July 1901 through July 1927)
Division of Chemistry, USDA (Established 1862)
Jurisdiction Federal government of the United States
Head quarters 10903 New HampshireAve, Silver Spring, MD 20903
Employees 11,516
Annual budget $2.3 billion
Agency executive Margaret A. Hamburg, Commissioner of Food and Drugs
Parent agency Department of Health and Human Services
Website fda.gov
3 04/28/16
Sagar Kishor Savale
4. INTRODUCTION
4
• The Food and DrugAdministration (FDA or USFDA) is an agency of
the United States Department of Health and Human Services, one of
the United States federal executive departments.
• The FDA is responsible for protecting and promoting public health
through the regulation and supervision of food safety, tobacco
products, dietary supplements, prescription and over-the-counter
pharmaceutical drugs (medications), vaccines, biopharmaceuticals,
blood transfusions, medical devices, electromagnetic radiation
emitting devices (ERED), veterinary products, and cosmetics.
• The FDA also enforces other laws, notably Section 361 of the Public
Health Service Act and associated regulations, many of which are not
directly related to food or drugs.
• These include sanitation requirements on interstate travel and control
of disease on products ranging from certain household pets to sperm
donation for assisted reproduction.
04/28/16
Sagar Kishor Savale
5. HISTORY OF FDA
5
In June 1906, President Theodore Roosevelt signed into law the Food
and Drug Act, also known as the "Wiley Act" after its chief advocate.
The act applied penalties to the interstate marketing of "adulterated"
drugs, in which the "standard of strength, quality, or purity" of the active
ingredient was not either stated clearly on the label or listed in the
United States Pharmacopoeia or the National Formulary.
The act also banned "misbranding" of food and drugs. The responsibility
for examining food and drugs for such "adulteration" or "misbranding"
was given to Wiley's USDA Bureau of Chemistry.
Wiley used these new regulatory powers to pursue an aggressive
campaign against the manufacturers of foods with chemical additives,
but the Chemistry Bureau's authority was soon checked by judicial
decisions, as well as by the creation of the Board of Food and Drug
Inspection and the Referee Board of Consulting Scientific Experts as
separate organizations within the USDA in 1907 and 1908 respectively.
04/28/16
Sagar Kishor Savale
6. 6
A 1911 Supreme Court decision ruled that the 1906 act did not apply to false
claims of therapeutic efficacy in response to which a 1912 amendment added
"false and fraudulent" claims of "curative or therapeutic effect" to the Act's
definition of "misbranded.“
However, these powers continued to be narrowly defined by the courts, which
set high standards for proof of fraudulent intent.
In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a
new USDA body, the Food, Drug, and Insecticide organization.
This name was shortened to the Food and Drug Administration (FDA) three
years later.
04/28/16
Sagar Kishor Savale
7. RESPONSIBILITY OF FDA
7
Protecting the public health by assuring that foods are safe, wholesome,
sanitary and properly labeled; human and veterinary drugs, and vaccines
and other biological products and medical devices intended for human use
are safe and effective.
Protecting the public from electronic product radiation.
Assuring cosmetics and dietary supplements are safe and properly labeled
Regulating tobacco products.
Helping the public get the accurate science-based information they need
to use medicines, devices, and foods to improve their health.
FDA’s responsibilities extend to the 50 United States, the District of
Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and
other U.S. territories and possessions.
04/28/16
Sagar Kishor Savale
8. 8
The FDA is led by the Commissioner of Food and Drugs, appointed by the President with
the advice and consent of the Senate.
The Commissioner reports to the Secretary of Health and Human Services.
The 21st and current Commissioner is Dr. Margaret A. Hamburg. She has served as
Commissioner since February 2009.
FDA consists of six product centers, one research center, and two offices –
Center for Biologics Evaluation and Research - which regulates products such as
vaccines, blood, and gene therapy.
Center for Devices and Radiological Health - which regulates medical devices
ranging from thermometers to kidney dialysis machines, and electronic products that give
off radiation, such as microwave ovens.
Margaret A. Hamburg, M.D.
Commissioner Of Food and Drugs
ORGANIZATION OF FDA
04/28/16
Sagar Kishor Savale
9. 9
Center for Drug Evaluation and Research - which regulates over-the-counter
and prescription medications.
Center for Food Safety and Applied Nutrition- which regulates most foods
(except meat and poultry, which are regulated by the U.S. Department of
Agriculture), food additives, infant formulas, dietary supplements, and cosmetics.
Center forTobacco Products - which regulates cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco.
Center forVeterinary Medicine_
which regulates feed and drugs and devices
used in pets, farm animals, and other animals.
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10. 10
National Center forToxicological Research- which supports FDA’s
product centers by providing innovative scientific technology, training, and
technical expertise.
Office Of Regulatory Affairs- which conducts inspections and enforces
FDA regulations.
Office of the Commissioner-which provides leadership and direction to
FDA’s product centers, research center, and Office of RegulatoryAffairs.
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11. CONSTITUTION
11
• USFDA has over 11516 employees, located in 167 U.S. cities. Among
its staff, FDA has chemists, microbiologist, and other scientists, as well
as investigators and inspectors who visit 16000 facilities a year as part
of their oversight of the business that FDA regulates.
• The FDA has its headquarters at Silver Spring, Maryland and has 223
field offices and 13 laboratories located throughout the 50 states, the
United States Virgin Islands, and Puerto Rico.
• In 2008, the FDA started opening offices in foreign countries, including
China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
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12. 12
• As of Oct. 1, 2009, FDA employs the following numbers of people
in its centers/offices:
Center for Biologics Evaluation and Research (CBER) 946
Center for Drug Evaluation and Research (CDER) 2,889
Center for Devices and Radiological Health (CDRH) 1,203
Center for Food Safety and Applied Nutrition (CFSAN) 877
Center for Tobacco Products (CTP) 194
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13. FDA ADVISORY COMMITTEE
13
Advisory committees provide FDA with independent advice from outside
experts on issues related to human and veterinary drugs, vaccines and
other biological products, medical devices, and food.
In general, advisory committees include a chair, several members, plus a
consumer, industry, and sometimes a patient representative.
Additional experts with special knowledge may be added for individual
committee meetings as needed.
Although the committees provide advice to the agency, FDA makes the
final decisions.
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14. How DOES AN INDIVIDUAL BECOME A
MEMBER OF AN FDA ADVISORY COMMITTEE?
14
Professional societies; industry, consumer, and patient advocacy groups;
or other interested people may nominate scientific members and
consumer, industry, and patient representatives. In addition, individuals
who want to serve on a committee may nominate themselves.
FDA requests that candidates provide detailed information regarding
financial holdings, employment, research grants and contracts, and other
potential conflicts of interest that may rule out membership.
The Food and Drug Administration, to assist in its mission to protect and
promote the public health, uses 49 committees and panels to obtain
independent expert advice on scientific, technical, and policy matters.
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15. SCOPE AND FUNDING
15
The FDA regulates more than $1 trillion worth of consumer goods,
about 25% of consumer expenditures in the United States.
This includes $466 billion in food sales, $275 billion in drugs, $60
billion in cosmetics and $18 billion in vitamin supplements.
Much of the expenditures is for goods imported into the United States;
the FDA is responsible for monitoring a third of all imports.
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16. LEGAL AUTHORITY Of FDA
16
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic
Act,(first passed in 1938 and extensively amended since) and are codified in Title
21, Chapter 9 of the United States Code.
Other significant laws enforced by the FDA include the Public Health Service Act,
parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as
many others. In many cases these responsibilities are shared with other federal
agencies.
Important enabling legislation of the FDA includes :
1902 – Biologics Control Act
1906 – Pure Food and Drug Act
1938 – Federal Food, Drug, and Cosmetic Act
1944 – Public Health Service Act
1951 – Food, Drug, and Cosmetics Act Amendments 04/28/16
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17. 17
1962 – Food, Drug, and Cosmetics Act Amendments
1966 – Fair Packaging and Labeling Act
1976 – Medical Device Regulation Act
1987 – Prescription Drug Marketing Act
1988 – Anti–drug Abuse Act
1990 – Nutrition Labeling and Education Act
1992 – Prescription Drug User Fee Act
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18. 1994 – Dietary Supplement Health and Education Act
1997 – Food and Drug Administration Modernization Act
2002 – Bioterrorism Act
2002 – Medical Device User Fee and Modernization Act (MDUFMA)
2003 – Animal Drug User Fee Act
2007 – Food and Drug Administration Amendments Act of 2007
2009 – Family Smoking Prevention and Tobacco Control Act
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19. MISSION OF FDA
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• To promote the public health by promptly and efficiently reviewing
clinical research and taking appropriate action on the marketing of
regulated products in a timely manner.
• With respect to such products, protect the public health by ensuring
that the food are safe, Wholesome, sanitary, and properly labelled;
human and veterinary drugs are safe and effective; there is reasonable
assurance of the safety and effectiveness of devices intended for human
use; cosmetics are safe and properly labelled, and public health and
safety are protected from the electronic product radiation.
• Participates through appropriate process with representatives of other
countries to reduce the burden of regulation, harmonize regulatory
requirements, and achieve appropriate arrangements.
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20. WHAT USFDA REGULATES?
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• Biologics
• Food additives
• Dietary supplements
• Product standards and develop improved testing's methods
• Cosmetics
• Labeling
• OTC and prescription drug labeling
• Drug manufacturing standards
• Foods
• Safety of all food products ( except meat and poultry)
• Medical devices from simple items like tongue depressors, to complex
technologies such as heart pacemakers
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21. 21
• Drugs (OTC and prescription drug )
• Radiation-Emitting Electronic Products
• Radiation safety performance standards for microwave ovens,
television receivers, diagnostic x-rays equipment, cabinet x-ray
system ( such as baggage x-rays at airports ), Laser products,
ultrasonic therapy equipment, mercury vapour lamps
• Veterinary drugs and devices
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22. WHAT USFDA DOES NOT REGULATE ?
22
• Advertising - except for prescription drugs, medical devices, and
tobacco products
• Alcohol beverages
• Consumer Products - paint, child-resistant packages, baby toys, and
household appliances (except for those that give off
radiation)
• Drugs of Abuse - heroin and marijuana
• Health Insurance
• Meat and Poultry - except for game meats, such as venison, ostrich, an
snake
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23. • Pesticides
• Restaurants and Grocery Stores
• Water
FDA shares the responsibility for regulating these products with
other government agencies :
• pesticides (FDA, the U.S. Department of Agriculture, and the
Environmental Protection Agency )
• water (FDA regulates the labeling and safety of bottled water, while the
Environmental Protection Agency develops national standards for
drinking water from municipal water supplies)
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24. RECENT UPDATE……
24
The FDA currently has regulatory oversight over a large array of products that
affect the health and life of American citizens. As a result, the FDA's powers
and decisions are carefully monitored by several governmental and non-
governmental organizations.
In 2006 Institute of Medicine report on pharmaceutical regulation in the U.S.
found major deficiencies in the current FDA system for ensuring the safety of
drugs on the American market.
Overall, the authors called for an increase in the regulatory powers, funding,
and independence of the FDA.
Nine FDA scientists appealed to then president-elect Barack Obama over
pressures from management, experienced during the George W. Bush
presidency, to manipulate data, including in relation to the review process for
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25. FDA Food Safety Modernization Act
25
The FDA Food Safety Modernization Act is a federal statute signed
into law by President Barack Obama on January 4, 2011.
The law authorizes the Food and Drug Administration (FDA) and the
Secretary of Health and Human Services (HHS) to increase
inspections of many domestic food facilities, enhance detection of
food borne illness outbreaks, and order recalls of tainted food
products.
The law requires most food companies to write and implement new
safety protocols to mitigate potential hazards.
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26. 26
President Barack Obama signs the FDA Food Safety
Modernization Act into law
Also, imported food products face increased scrutiny under the law, including denial of
entry into the United States under certain circumstances.
It is the most significant update of American food safety laws since the Federal Food,
Drug, and Cosmetic Act in 1938.
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27. REFERENCES
27
Dr. B.S. Kuchekar, Mr. A.M. Khadatare, FORENSIC PHARMACY 7th
Edition August 2007 Published By- NIRALI PRAKASHAN ,PP-17.8
to 17.11, 17.25 to 17.28
Sachin C. Itkar, PHARMACEUTICAL MANAGEMENT 3rd
Edition
May 2007 Published By- NIRALI PRAKASHAN ,PP-18.1 to 18.4 ,
18.21 to 18.24
www.fda.gov
www.wikepedia.com
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