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.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
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 reciprocal arrangements.
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
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
Regulatory authorities (US-FDA, WHO and ICH)Sagar Savale
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 reciprocal arrangements.
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
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
Intellectual Property Rights In India: Patents Trademarks And Copyrights JRA & Associates
Intellectual property (IP) refers to creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce.
IP is protected in law by, for example, patents, copyright and trademarks, which enable people to earn recognition or financial benefit from what they invent or create. By striking the right balance between the interests of innovators and the wider public interest, the IP system aims to foster an environment in which creativity and innovation can flourish.
Let us try and understand the basics of these intellectual property rights, how they can be applied for in India and understand how and why they are litigated so fiercely.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"
How EPA plans will implement Cap & Trade, increase federal spending, negatively impact state/municipal budgets, eliminate jobs, and hurt industry/businesses
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Differences between Verification, Calibration and Validation
Dr. Deepak
December 8, 2017
7 Comments
Data Scrutiny is important before reporting
Data Scrutiny is important before reporting
You have perhaps come across these terms in laboratory documents and wondered that they convey the same meaning so where is the need for different terminology.
A little insight will help you understand the fine differences between them. Giving their concise definitions may suffice to gain a basic understanding but to help you get a clearer understanding I have attempted to offer clarity on the terms in context of routine activities in analytical laboratories as I believe that giving real life examples rather than recalling definitions serves the purpose better and makes you remember what is being conveyed longer.
Along with their definitions, I have also pointed out the difference between calibration and validation, and also the difference between calibration and verification. So you will be able to use these terms appropriately.
Let’s first explore what these terms mean:
Verification
In simple terms verification means confirming the authenticity of activities or data before communication to concerned parties. It is important that the results communicated by you are free from errors. Essentially verification comprises of multiple checks on supplies, samples and data before forwarding the results of your testing activities. Majority of the checks can be carried out by you but it is advised that independent assistance be taken for rechecking the data before submission.
Self Checks
The Correct sample was taken up for analysis.
The Sample description, analysis instructions were verified before start of analysis.
The Equipment and glassware used were calibrated.
Recommended grades of chemicals from reliable sources were used.
Weight readings were correctly recorded and entered in calculations.
Recommended environmental conditions were maintained throughout the analysis.
Independent checks
It is strongly recommended that independent rechecking be carried out by a set of trained individuals before the analysis results are consolidated for report generation.
The Sample is analyzed as per the customer’s requirements. As an example in pharmaceutical analysis the tests are conducted in compliance with USP, BP, IP, etc.
If sample information such as name, batch number, date of manufacture, date of expiry, sample source, etc are entered correctly or not in reports.
Entered data matches with the data in the w
Calibration of laboratory instrum
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.
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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.
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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
04/28/16Sagar 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 04/28/16Sagar 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.
04/28/16Sagar 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.
04/28/16Sagar 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.
04/28/16Sagar 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.
04/28/16Sagar 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
04/28/16Sagar 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.
04/28/16Sagar Kishor Savale
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.
04/28/16Sagar Kishor Savale
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.
04/28/16Sagar Kishor Savale
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
04/28/16Sagar Kishor Savale
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.
04/28/16Sagar Kishor Savale
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.
04/28/16Sagar Kishor Savale
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.
04/28/16Sagar Kishor Savale
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 04/28/16Sagar Kishor Savale
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
04/28/16Sagar Kishor Savale
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
18 04/28/16Sagar Kishor Savale
19. MISSION OF FDA
19
• 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.
04/28/16Sagar Kishor Savale
20. WHAT USFDA REGULATES?
20
• 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
04/28/16Sagar Kishor Savale
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
04/28/16Sagar Kishor Savale
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
04/28/16Sagar Kishor Savale
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
medical devices. 04/28/16Sagar Kishor Savale
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.
04/28/16Sagar Kishor Savale
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.
04/28/16Sagar Kishor Savale
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
04/28/16Sagar Kishor Savale