Current US drug regulations originated from two early 1900s laws motivated by racism and fears about drug use. The 1906 Pure Food and Drugs Act and 1914 Harrison Act established regulatory frameworks for drug purity and taxation respectively. Over time, laws and agencies were established to require safety and efficacy testing for new drugs while dietary supplements face less stringent regulation. Controlled substances are classified by abuse and medical use potential and penalties have increased for illegal use and sales.
This document discusses the history and development of drug regulation in the United States. It notes that current drug laws trace back to the Pure Food and Drugs Act of 1906 and Harrison Act of 1914, which were influenced by concerns over fraudulent and dangerous patent medicines as well as fears about recreational drug use. Over time, these laws have been amended and updated, including through the 1970 Controlled Substances Act, to establish a drug scheduling system and further regulate pharmaceutical research, approval, and prescription. The impacts and effectiveness of this increasingly strict regulatory system continue to be debated.
This document discusses the history and development of drug regulation in the United States. It notes that current drug laws trace back to the Pure Food and Drugs Act of 1906 and the Harrison Act of 1914. The 1906 act was intended to ensure drug purity and honest labeling under the Department of Agriculture. The 1914 act aimed to restrict opioid and cocaine commerce through taxation under the Treasury Department. Over time, laws and the FDA have imposed greater requirements for pre-market testing, approval, and proving drug safety and effectiveness.
This document summarizes the history of drug laws in the United States from the 1700s to present day. It discusses early regulation of alcohol and opium, the 1906 Pure Food and Drug Act, the Harrison Narcotic Act of 1914, prohibition, the Marihuana Tax Act of 1937, and major drug laws passed in the 1960s-2000s that aimed to increase drug safety regulations, control narcotics, and enforce harsher penalties for drug offenses. It also explores debates around decriminalization, legalization, harm reduction strategies, and the impacts of the war on drugs.
This document summarizes the history of drug laws in the United States from the colonial period to modern times. It discusses how the first substances regulated were alcohol and opium in the late 18th/early 19th centuries. Major milestones include the 1906 Pure Food and Drug Act, the 1914 Harrison Narcotics Tax Act, marijuana prohibition in 1937, and the 1970 Controlled Substances Act. The document also examines debates around approaches to drug policy enforcement versus treatment.
This document discusses the history and development of drug regulation in the United States. It notes that current drug laws trace back to the Pure Food and Drugs Act of 1906 and Harrison Act of 1914, which were influenced by concerns over fraudulent and dangerous patent medicines as well as fears about recreational drug use. Over time, these laws have been amended and updated, including through the 1970 Controlled Substances Act, to establish a drug scheduling system and further regulate pharmaceutical research, approval, and prescription. The impacts and effectiveness of this increasingly strict drug enforcement approach are still being debated.
This document discusses the history and development of drug regulation in the United States. It notes that current drug laws trace back to the Pure Food and Drugs Act of 1906 and Harrison Act of 1914, which were influenced by concerns over fraudulent and dangerous patent medicines as well as fears about recreational drug use. Over time, these laws have been amended and updated, including through the 1970 Controlled Substances Act, to establish a drug scheduling system and further regulate pharmaceutical research, approval, and prescription. The impacts and effectiveness of this increasingly strict drug enforcement approach are still being debated.
The 1970 Comprehensive Drug Abuse Prevention and Control Act replaced all previous drug laws, put drugs under federal control, and increased funding for prevention and treatment. It classified drugs into 5 schedules based on their medical use and abuse potential, and assigned penalties for illegal drug manufacture, distribution, and possession. The Act also established rules for prescribing physicians and has been amended several times since.
Drug Use, Regulation, and the LawChapter 3Guid.docxjacksnathalie
This document discusses guidelines for controlling drug development and marketing, including strategies for preventing drug abuse through supply reduction, inoculation, and demand reduction. It also summarizes regulations that have been implemented related to drug labeling, safety testing, and advertising in response to issues like fraudulent patent medicines and the thalidomide tragedy. Current drug scheduling is explained based on abuse potential and medical usefulness.
This document discusses the history and development of drug regulation in the United States. It notes that current drug laws trace back to the Pure Food and Drugs Act of 1906 and Harrison Act of 1914, which were influenced by concerns over fraudulent and dangerous patent medicines as well as fears about recreational drug use. Over time, these laws have been amended and updated, including through the 1970 Controlled Substances Act, to establish a drug scheduling system and further regulate pharmaceutical research, approval, and prescription. The impacts and effectiveness of this increasingly strict regulatory system continue to be debated.
This document discusses the history and development of drug regulation in the United States. It notes that current drug laws trace back to the Pure Food and Drugs Act of 1906 and the Harrison Act of 1914. The 1906 act was intended to ensure drug purity and honest labeling under the Department of Agriculture. The 1914 act aimed to restrict opioid and cocaine commerce through taxation under the Treasury Department. Over time, laws and the FDA have imposed greater requirements for pre-market testing, approval, and proving drug safety and effectiveness.
This document summarizes the history of drug laws in the United States from the 1700s to present day. It discusses early regulation of alcohol and opium, the 1906 Pure Food and Drug Act, the Harrison Narcotic Act of 1914, prohibition, the Marihuana Tax Act of 1937, and major drug laws passed in the 1960s-2000s that aimed to increase drug safety regulations, control narcotics, and enforce harsher penalties for drug offenses. It also explores debates around decriminalization, legalization, harm reduction strategies, and the impacts of the war on drugs.
This document summarizes the history of drug laws in the United States from the colonial period to modern times. It discusses how the first substances regulated were alcohol and opium in the late 18th/early 19th centuries. Major milestones include the 1906 Pure Food and Drug Act, the 1914 Harrison Narcotics Tax Act, marijuana prohibition in 1937, and the 1970 Controlled Substances Act. The document also examines debates around approaches to drug policy enforcement versus treatment.
This document discusses the history and development of drug regulation in the United States. It notes that current drug laws trace back to the Pure Food and Drugs Act of 1906 and Harrison Act of 1914, which were influenced by concerns over fraudulent and dangerous patent medicines as well as fears about recreational drug use. Over time, these laws have been amended and updated, including through the 1970 Controlled Substances Act, to establish a drug scheduling system and further regulate pharmaceutical research, approval, and prescription. The impacts and effectiveness of this increasingly strict drug enforcement approach are still being debated.
This document discusses the history and development of drug regulation in the United States. It notes that current drug laws trace back to the Pure Food and Drugs Act of 1906 and Harrison Act of 1914, which were influenced by concerns over fraudulent and dangerous patent medicines as well as fears about recreational drug use. Over time, these laws have been amended and updated, including through the 1970 Controlled Substances Act, to establish a drug scheduling system and further regulate pharmaceutical research, approval, and prescription. The impacts and effectiveness of this increasingly strict drug enforcement approach are still being debated.
The 1970 Comprehensive Drug Abuse Prevention and Control Act replaced all previous drug laws, put drugs under federal control, and increased funding for prevention and treatment. It classified drugs into 5 schedules based on their medical use and abuse potential, and assigned penalties for illegal drug manufacture, distribution, and possession. The Act also established rules for prescribing physicians and has been amended several times since.
Drug Use, Regulation, and the LawChapter 3Guid.docxjacksnathalie
This document discusses guidelines for controlling drug development and marketing, including strategies for preventing drug abuse through supply reduction, inoculation, and demand reduction. It also summarizes regulations that have been implemented related to drug labeling, safety testing, and advertising in response to issues like fraudulent patent medicines and the thalidomide tragedy. Current drug scheduling is explained based on abuse potential and medical usefulness.
The document discusses the history of drug regulation laws in the United States from the early 1900s to present day. It covers major milestones like the 1906 Pure Food and Drug Act, the Food, Drug and Cosmetic Act of 1938, and the Controlled Substances Act of 1970 which categorized drugs based on their medical use and abuse potential. The challenges around balancing public health, crime prevention, and civil liberties in developing drug laws are also examined.
The document provides information about taxes of pharmaceuticals in India. It discusses the impact of Goods and Service Tax (GST) on the pharmaceutical industry, including procurement, manufacture, sales and distribution, pricing, services, and IT changes. It also mentions direct taxes and tax structure incentives for the pharmaceutical sector as well as indirect taxes like custom duty and central excise duty. The document includes a table comparing the pre-GST and post-GST prices of four drugs manufactured in India, showing an average increase in tax value of around 40-50% after GST implementation.
The document discusses the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Kefauver-Harris Amendments of 1962. The FFDCA was passed in 1938 in response to tragedies from unsafe drugs and gave more authority to the FDA. The Kefauver-Harris Amendments of 1962 required drug manufacturers to prove a drug's efficacy and safety before approval in response to the thalidomide crisis. The amendments strengthened pre-market drug approval processes and mandated new drug efficacy studies.
The document outlines the history and key pieces of legislation regulating drugs in the United States, beginning with the 1906 Pure Food and Drug Act which aimed to prohibit misbranded and adulterated drugs. Major laws included the 1938 Federal Food, Drug, and Cosmetic Act which gave the FDA power to ensure drug safety, the 1970 Controlled Substances Act which classified drugs into schedules based on abuse potential, and the 1996 Health Insurance Portability and Accountability Act (HIPAA) which provided privacy protections for patient health information. The legislation established the FDA and DEA and granted them authority to approve, schedule, and regulate drugs.
The document discusses ethics in the pharmaceutical industry. It covers topics like the history and regulation of the industry, ethical and unethical business practices, laws and regulations, the role of patents and generics, good manufacturing practices, and the role of industrial pharmacists. It also provides examples of ethical violations by pharmaceutical companies.
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.
The document discusses government regulation of food and drug safety in the United States. It notes that responsibility is divided between multiple agencies, including the Department of Agriculture (USDA) which regulates meat and poultry, and the Food and Drug Administration (FDA) which regulates all other foods. However, the FDA has a smaller budget and less regulatory authority than the USDA despite regulating most foods. The document also outlines various food and drug safety measures, controversies around clinical drug trials and dietary supplements, and politics around the FDA approval process.
The document summarizes the historical aspects of the new drug approval process in the United States. It outlines the key events and legislation that established regulations for drug safety, including the 1906 Food and Drug Act, the 1938 Food, Drug, and Cosmetic Act, the 1962 Kefauver-Harris Amendments requiring proof of efficacy, and the 1992 Prescription Drug User Fee Act expediting the review process. The document provides an overview of the clinical trial phases and FDA review process required to demonstrate a drug is safe and effective before approval and public use.
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
The document discusses the changing policy landscape around complementary and alternative medicine (CAM) in the United States over the past 50 years. It describes how the 1938 Federal Food, Drug, and Cosmetic Act originally tightly regulated CAM products and claims. However, the 1994 Dietary Supplement Health and Education Act significantly weakened the FDA's ability to regulate supplements. The 2000 White House Commission on Complementary and Alternative Medicine Policy further promoted CAM. The effect has been to move US policy from actively discouraging CAM to embracing it, driven largely by private industry interests in the commercial CAM market.
The US Food and Drug Administration (FDA) is responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and tobacco. The FDA oversees products representing 25% of US consumer spending. It has over 11,500 employees located across the country and overseas. The FDA regulates a wide range of products and enforces numerous laws relating to public health and safety. Its mission is to promote public health by reviewing research and regulating products efficiently.
This document provides an overview of drug regulatory affairs. It defines regulatory affairs as the profession that acts as the interface between pharmaceutical industries and drug regulatory authorities. The goal of regulatory affairs professionals is to protect human health by ensuring safety, efficacy and quality of drugs and ensuring accurate product information. It discusses why regulatory affairs is needed, highlighting past drug tragedies that led to increased regulation. Regulatory affairs helps reduce development failures and provides assistance on issues like licensing, registration, development, manufacturing and quality guidance.
This document provides an overview of drug regulatory affairs. It discusses the learning objectives which are to gain knowledge about regulatory processes, laws, and working within a regulatory environment. It defines regulatory affairs as the interface between pharmaceutical companies and drug authorities. The goal is to ensure safety, efficacy and quality of drugs. It discusses some drug tragedies in the past that led to the need for regulatory affairs and authorities like the FDA. Regulatory affairs professionals help companies work within this regulatory system and reduce development failures. Their role is to gather relevant information and assist companies on various regulatory issues from licensing to pharmacovigilance. Major global regulatory authorities are also named.
This document summarizes the history of drug regulation laws in the United States from the early 1900s to present day. It covers major acts like the 1906 Pure Food and Drug Act, the 1970 Controlled Substances Act, and amendments that strengthened safety requirements for clinical drug trials and approval processes. Key topics discussed include scheduling of controlled substances, exceptions for fast-tracking new drugs, switching drugs from prescription to over-the-counter status, advertising regulations, and strategies for preventing drug abuse through education, treatment programs, and drug testing.
This document summarizes the history of drug regulation laws in the United States from the early 1900s to present day. It covers major milestones like the 1906 Pure Food and Drug Act, the 1970 Controlled Substances Act, and exceptions for drug approval like orphan drugs and fast-tracking. Key issues discussed are balancing public health with criminalization, determining appropriate drug schedules, and strategies for preventing drug abuse like education, treatment, and drug testing.
The document discusses the history of drug regulation laws in the United States from the early 1900s to present day. It covers major acts and amendments that aimed to regulate drugs and drug development, including the 1906 Pure Food and Drug Act, Harrison Act of 1914, 1970 Controlled Substances Act, and Kefauver-Harris Amendments. The "War on Drugs" of the 1980s is also summarized, which took a criminal justice approach to drug abuse. Prevention strategies discussed include supply reduction, demand reduction, and harm reduction approaches.
This document discusses regulatory affairs related to pharmacy practice in India. It outlines several key laws that pharmacists must adhere to, including the Drugs and Cosmetics Act of 1940, the Narcotic Drugs and Psychotropic Substances Act of 1985, the Drugs Price Control Order of 1995, and the Consumer Protection Act of 1986. The document also describes legal aspects of dispensing medications, such as prescription requirements, medication schedules, emergency supplies, and record keeping. Overall, it emphasizes that following all applicable laws is essential for pharmacists to provide safe and effective healthcare while protecting patient safety.
The drug approval process in the US has evolved over time in response to safety issues and public health crises. It began with the 1906 Pure Food and Drugs Act which required safety and purity standards but no pre-approval of drugs. Subsequent laws in 1938, 1962, and beyond introduced pre-market testing requirements and phases to demonstrate safety and efficacy. The modern multi-step approval process evaluates drugs in laboratories, animals and increasing levels of human trials over 6-8 years before approval. Reforms have aimed to incentivize new treatments while protecting patients.
- The document outlines the major steps in the US drug approval process, including preclinical testing in animals, filing an Investigational New Drug (IND) application with the FDA to begin clinical trials, and completing four phases of clinical trials on humans. It also defines key terms and legislative acts that have shaped the current drug regulation system.
- It describes the four phases of clinical trials that increase in size and explore safety, efficacy, optimal dosing, and comparison to existing treatments. After phase III trials, a New Drug Application is submitted to the FDA for marketing approval review.
- The drug approval process is designed to demonstrate a drug is safe and effective before being approved and made available to the public, as
Antitrust Aspects of Acquiring a Generic Drug ManufacturerNexsen Pruet
The document discusses antitrust issues related to acquisitions of generic drug manufacturers, including an overview of FTC enforcement actions challenging mergers in this industry from 1995 to present. It outlines criteria the FTC applies in their analysis, such as the impact of branded drugs on generics, delivery methods, number of competitors, and parties' innovation pipelines. The FTC takes into account these factors to determine whether a merger will reduce competition and harm consumers in generic drug markets.
The document discusses the history of drug regulation laws in the United States from the early 1900s to present day. It covers major milestones like the 1906 Pure Food and Drug Act, the Food, Drug and Cosmetic Act of 1938, and the Controlled Substances Act of 1970 which categorized drugs based on their medical use and abuse potential. The challenges around balancing public health, crime prevention, and civil liberties in developing drug laws are also examined.
The document provides information about taxes of pharmaceuticals in India. It discusses the impact of Goods and Service Tax (GST) on the pharmaceutical industry, including procurement, manufacture, sales and distribution, pricing, services, and IT changes. It also mentions direct taxes and tax structure incentives for the pharmaceutical sector as well as indirect taxes like custom duty and central excise duty. The document includes a table comparing the pre-GST and post-GST prices of four drugs manufactured in India, showing an average increase in tax value of around 40-50% after GST implementation.
The document discusses the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Kefauver-Harris Amendments of 1962. The FFDCA was passed in 1938 in response to tragedies from unsafe drugs and gave more authority to the FDA. The Kefauver-Harris Amendments of 1962 required drug manufacturers to prove a drug's efficacy and safety before approval in response to the thalidomide crisis. The amendments strengthened pre-market drug approval processes and mandated new drug efficacy studies.
The document outlines the history and key pieces of legislation regulating drugs in the United States, beginning with the 1906 Pure Food and Drug Act which aimed to prohibit misbranded and adulterated drugs. Major laws included the 1938 Federal Food, Drug, and Cosmetic Act which gave the FDA power to ensure drug safety, the 1970 Controlled Substances Act which classified drugs into schedules based on abuse potential, and the 1996 Health Insurance Portability and Accountability Act (HIPAA) which provided privacy protections for patient health information. The legislation established the FDA and DEA and granted them authority to approve, schedule, and regulate drugs.
The document discusses ethics in the pharmaceutical industry. It covers topics like the history and regulation of the industry, ethical and unethical business practices, laws and regulations, the role of patents and generics, good manufacturing practices, and the role of industrial pharmacists. It also provides examples of ethical violations by pharmaceutical companies.
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.
The document discusses government regulation of food and drug safety in the United States. It notes that responsibility is divided between multiple agencies, including the Department of Agriculture (USDA) which regulates meat and poultry, and the Food and Drug Administration (FDA) which regulates all other foods. However, the FDA has a smaller budget and less regulatory authority than the USDA despite regulating most foods. The document also outlines various food and drug safety measures, controversies around clinical drug trials and dietary supplements, and politics around the FDA approval process.
The document summarizes the historical aspects of the new drug approval process in the United States. It outlines the key events and legislation that established regulations for drug safety, including the 1906 Food and Drug Act, the 1938 Food, Drug, and Cosmetic Act, the 1962 Kefauver-Harris Amendments requiring proof of efficacy, and the 1992 Prescription Drug User Fee Act expediting the review process. The document provides an overview of the clinical trial phases and FDA review process required to demonstrate a drug is safe and effective before approval and public use.
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
The document discusses the changing policy landscape around complementary and alternative medicine (CAM) in the United States over the past 50 years. It describes how the 1938 Federal Food, Drug, and Cosmetic Act originally tightly regulated CAM products and claims. However, the 1994 Dietary Supplement Health and Education Act significantly weakened the FDA's ability to regulate supplements. The 2000 White House Commission on Complementary and Alternative Medicine Policy further promoted CAM. The effect has been to move US policy from actively discouraging CAM to embracing it, driven largely by private industry interests in the commercial CAM market.
The US Food and Drug Administration (FDA) is responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, and tobacco. The FDA oversees products representing 25% of US consumer spending. It has over 11,500 employees located across the country and overseas. The FDA regulates a wide range of products and enforces numerous laws relating to public health and safety. Its mission is to promote public health by reviewing research and regulating products efficiently.
This document provides an overview of drug regulatory affairs. It defines regulatory affairs as the profession that acts as the interface between pharmaceutical industries and drug regulatory authorities. The goal of regulatory affairs professionals is to protect human health by ensuring safety, efficacy and quality of drugs and ensuring accurate product information. It discusses why regulatory affairs is needed, highlighting past drug tragedies that led to increased regulation. Regulatory affairs helps reduce development failures and provides assistance on issues like licensing, registration, development, manufacturing and quality guidance.
This document provides an overview of drug regulatory affairs. It discusses the learning objectives which are to gain knowledge about regulatory processes, laws, and working within a regulatory environment. It defines regulatory affairs as the interface between pharmaceutical companies and drug authorities. The goal is to ensure safety, efficacy and quality of drugs. It discusses some drug tragedies in the past that led to the need for regulatory affairs and authorities like the FDA. Regulatory affairs professionals help companies work within this regulatory system and reduce development failures. Their role is to gather relevant information and assist companies on various regulatory issues from licensing to pharmacovigilance. Major global regulatory authorities are also named.
This document summarizes the history of drug regulation laws in the United States from the early 1900s to present day. It covers major acts like the 1906 Pure Food and Drug Act, the 1970 Controlled Substances Act, and amendments that strengthened safety requirements for clinical drug trials and approval processes. Key topics discussed include scheduling of controlled substances, exceptions for fast-tracking new drugs, switching drugs from prescription to over-the-counter status, advertising regulations, and strategies for preventing drug abuse through education, treatment programs, and drug testing.
This document summarizes the history of drug regulation laws in the United States from the early 1900s to present day. It covers major milestones like the 1906 Pure Food and Drug Act, the 1970 Controlled Substances Act, and exceptions for drug approval like orphan drugs and fast-tracking. Key issues discussed are balancing public health with criminalization, determining appropriate drug schedules, and strategies for preventing drug abuse like education, treatment, and drug testing.
The document discusses the history of drug regulation laws in the United States from the early 1900s to present day. It covers major acts and amendments that aimed to regulate drugs and drug development, including the 1906 Pure Food and Drug Act, Harrison Act of 1914, 1970 Controlled Substances Act, and Kefauver-Harris Amendments. The "War on Drugs" of the 1980s is also summarized, which took a criminal justice approach to drug abuse. Prevention strategies discussed include supply reduction, demand reduction, and harm reduction approaches.
This document discusses regulatory affairs related to pharmacy practice in India. It outlines several key laws that pharmacists must adhere to, including the Drugs and Cosmetics Act of 1940, the Narcotic Drugs and Psychotropic Substances Act of 1985, the Drugs Price Control Order of 1995, and the Consumer Protection Act of 1986. The document also describes legal aspects of dispensing medications, such as prescription requirements, medication schedules, emergency supplies, and record keeping. Overall, it emphasizes that following all applicable laws is essential for pharmacists to provide safe and effective healthcare while protecting patient safety.
The drug approval process in the US has evolved over time in response to safety issues and public health crises. It began with the 1906 Pure Food and Drugs Act which required safety and purity standards but no pre-approval of drugs. Subsequent laws in 1938, 1962, and beyond introduced pre-market testing requirements and phases to demonstrate safety and efficacy. The modern multi-step approval process evaluates drugs in laboratories, animals and increasing levels of human trials over 6-8 years before approval. Reforms have aimed to incentivize new treatments while protecting patients.
- The document outlines the major steps in the US drug approval process, including preclinical testing in animals, filing an Investigational New Drug (IND) application with the FDA to begin clinical trials, and completing four phases of clinical trials on humans. It also defines key terms and legislative acts that have shaped the current drug regulation system.
- It describes the four phases of clinical trials that increase in size and explore safety, efficacy, optimal dosing, and comparison to existing treatments. After phase III trials, a New Drug Application is submitted to the FDA for marketing approval review.
- The drug approval process is designed to demonstrate a drug is safe and effective before being approved and made available to the public, as
Antitrust Aspects of Acquiring a Generic Drug ManufacturerNexsen Pruet
The document discusses antitrust issues related to acquisitions of generic drug manufacturers, including an overview of FTC enforcement actions challenging mergers in this industry from 1995 to present. It outlines criteria the FTC applies in their analysis, such as the impact of branded drugs on generics, delivery methods, number of competitors, and parties' innovation pipelines. The FTC takes into account these factors to determine whether a merger will reduce competition and harm consumers in generic drug markets.
Image sources: National Library of Medicine (Image Ch03_01CocaWine) Library of Congress Prints and Photographs Division (Image Ch03_02PatMedHoofland) PhotoLink/Getty Images (Image Ch03_11DrugDevelopment)
Image source: Library of Congress Prints and Photographs Division (Image Ch03_09OpiumPoster1)
Image source: Library of Congress Prints and Photographs Division (Images Ch03_06PatMedKentucky, Ch03_04PatMedJayne)
Image source: Library of Congress Prints and Photographs Division (Image Ch03_07ColliersMagazine)
Image source: Library of Congress Prints and Photographs Division (Image Ch03_08OpiumDen)
Image source: National Library of Medicine, National Institutes of Health (See image bank for Chapter 6; Image Ch06_07CocaineDrops)
Image source: U.S. Immigration and Customs Enforcement (Image Ch03_19SeizedEcstasy)
Image source: Library of Congress Prints and Photographs Division (Image Ch03_02PatMedHoofland) Image source: PhotoLink/Getty Images (Image Ch03_11DrugDevelopment)