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.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
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
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
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 requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
Intellectual Property Rights (IPRs) are legal rights that protect creations and/or inventions resulting from intellectual activity in the industrial, scientific, literary, or artistic fields. The most common IPRs include patents, copyrights, marks, and trade secrets and Regulatory affair is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines, and by the companies
Clinical Research Regulation in European Union ShantanuThakre3
- On 16 April 2014, the European Commission adopted the new Clinical Trial Regulation (EU No 536/2014), repealing Directive 2001/20/EC.
- Although the Clinical Trial Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the Clinical Trials Information System (CTIS) through an independent audit.
- The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation.
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.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
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 requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
Intellectual Property Rights (IPRs) are legal rights that protect creations and/or inventions resulting from intellectual activity in the industrial, scientific, literary, or artistic fields. The most common IPRs include patents, copyrights, marks, and trade secrets and Regulatory affair is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines, and by the companies
Clinical Research Regulation in European Union ShantanuThakre3
- On 16 April 2014, the European Commission adopted the new Clinical Trial Regulation (EU No 536/2014), repealing Directive 2001/20/EC.
- Although the Clinical Trial Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the Clinical Trials Information System (CTIS) through an independent audit.
- The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation.
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.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
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.
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
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.
Drug Use, Regulation, and the LawChapter 3Guid.docxjacksnathalie
Drug Use, Regulation,
and the Law
Chapter 3
Guidelines for Controlling Drug Development and Marketing
Society has the right to protect itself from the damaging impact of drug use.
Society has the right to demand safe and effective drugs.
Strategies for Preventing Drug Abuse
Supply reduction
Using drug laws to control the manufacturing and distribution of classified drugs
Inoculation
Aims to protect drug users by teaching them responsibility and explaining the effects of drugs on bodily and mental functioning
Demand reduction strategy
Aims to reduce the actual demand for drugs
3
Patent Medicines
The term patent medicines signified that the ingredients were secret, not patented.
The patent medicines of the late 1800s and early 1900s demonstrated the problems of insufficient regulation of the drug industry.
Issues Leading to Legislation
Fraud in patent medicines that were sold directly to the public
False therapeutic claims
Habit-forming drug content
5
Image source: Library of Congress Prints and Photographs Division (Images Ch03_05PatMedKentucky, Ch03_03PatMedJayne)
Issues Leading to Legislation
Cocaine
Present in many patent medicines
Viewed as a cause of increasing crime
6
Image source: National Library of Medicine, National Institutes of Health (See image bank for Chapter 6; Image Ch06_06CocaineDrops)
Reformism
Current laws trace back to two pieces of legislation from the early 1900s
Racist fears about deviant behavior, including drug misuse, played a role in the development of drug regulation
Laws were developed to regulate undesirable behaviors
7
Image source: Library of Congress Prints and Photographs Division (Image Ch03_08OpiumPoster1)
Issues Leading to Legislation
Opium and the Chinese
U.S. was involved in international drug trade
Opium smoking brought to U.S. by Chinese workers (myth)
Laws passed against the importation, manufacture, and use of opium
8
Image source: Library of Congress Prints and Photographs Division (Image Ch03_07OpiumDen)
Issues Leading to Legislation
In the early 1900s, Collier’s magazine ran a series of articles attacking patent medicines.
Drug manufacturers have a history of selling ineffective, addictive and even harmful products to the public.
9
Image source: Library of Congress Prints and Photographs Division (Image Ch03_06ColliersMagazine)
1906 Pure Food and Drugs Act
Federal government law to protect the public (Dept. of Agriculture)
Required accurate labeling and listing of ingredients
US Government intervenes in commerce of adulterated or misbranded drugs and food
Misbranding only refers to the label, not advertising
10
The 1906 Pure Food and Drug Act
Required manufacturers to include on labels the amounts of alcohol, morphine, opium, cocaine, heroin, or marijuana extract in each product
Did not prohibit distribution of dangerous preparations
The Sherley Amendment in 1912
Accuracy of manufacturers’ therapeutic claims was not controlled by the P ...
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.
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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
Research report on small molecules in multiple myeloma treatmentJamia Hamdard
It is an insight report of using drug molecules for the treatment of multiple myeloma. The report describes the regulatory approval product, secondary market research, key companies, filing country, and clinical trial.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
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Model Attribute Check Company Auto PropertyCeline George
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Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
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We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
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Chapter 3 - Islamic Banking Products and Services.pptx
Federal food, drug & cosmetics act
1. Federal Food, Drug & Cosmetics Act
Kefauver's-Harris Amendments
ABDUL MUHEEM
M.PHARMA 2ND SEM.
(PHARMACEUTICS)
JAMIA HAMADARD
muheem.abdul985@gmail.com
2.
3. OBJECTIVES OF FFDCA
In United States Federal Food, Drug, and Cosmetic
Act (FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving
authority to the U.S. Food and Drug Administration (FDA) to oversee the safety
of food, drugs, and cosmetics.
It replaced the earlier Pure Food and Drug Act of 1906 due to Elixir
Sulphanilamide disaster.
1938 Act continued the information provision requirements of
the 1906 Act. The classification “misbranded” was expanded
example, and now included any drug whose label failed to
identify and quantify the precise ingredients, to list effects
and possible side effects, and to give directions and
cautionary information.
1938 Act also expanded the FDA’s powers over medical
devices .
4.
5. Reason for implemented new act
1937 – sulfanilamide crisis
November 16, 1937:
A Senate resolution directs the U.S.
Department of Agriculture to give a
full accounting of the "Elixir
Sulfanilamide" tragedy. The
drug, containing a poisonous
solvent(ethylene glycol / propylene
glycol mix-up), was not safety tested
and has killed 107 persons, many of
them children. The incident made
Congress to pass the Federal
Food, Drug, and Cosmetic Act, which
includes stronger drug safety
requirements
6. OTHER TRAGEDIES
Koremlu Cream
Contained Thallium acetate
Serious hazardous side effects due to thallium
Radiothor
"Radium containing water“
Consumers died of radiation exposure
Label true and no therapeutic claims
7. Lack of standards for food products
Developments in Science and technology
Canning / Chemical analysis
Expansion of cosmetics industry
8. GOALS OF FDCA(1938)
The FDCA mandates the safety, purity, and in some cases the
"effectiveness" of the products within its scope.
FDA ensures safety through inspections of products already on
the market, controls the manufacturing practices of
companies, and possesses recall and seizure authority.
The FDCA's Goal is to disclose information- requires
truthfulness and completeness in product labeling and other
marketing communications.
The act forbids "misbranding," and provides a range of civil and
criminal enforcement mechanisms against inaccurate product
labeling.
Section contains both civil law and criminal law clauses.
The FDCA in 1958 with the Food Additives Amendment (also
called the "Delaney Clause" after its House sponsor), precluding
FDA approval of any food additive found to cause cancer in
humans or animals.
9. Food & drug act
Prohibited the sales of adulterated &misbranded drugs.
Drug could be marketed as long as the label did not present
false information regarding the strength & purity.
no requirement to disclose ingredients.
A largely unregulated industry was causing numerous public
health problems.
10.
11. CHAPTER WISE DESCRIPTION:
Chapter I. Short Titles
Chapter II – Definitions.
201(f) is the definition for a food, which explicitly includes chewing
gum
201(g) is the definition for a drug
201(h) is the definition for a medical device
201(s) is the definition of a food additive
201(ff) is the definition of a dietary supplement
12. CHAPTER III. Prohibited Acts and Penalties
301. Prohibited Acts
302. Injunction proceedings
303. Penalties
304. Seizures
305. Hearing before report of criminal violation
306. Report of minor violations
307. Proceedings in name of United States; provision as to
subpoenas .
13. CHAPTER IV. Food
401. Definitions and standards for food
402. Adulterated food
403. Misbranded food
404. Emergency permit control
405. Regulations making exemptions
406. Tolerances for poisonous ingredients in food
407. Oleomargarine or margarine
408. Tolerances for pesticide chemicals in or
on raw agricultural commodities
409. Food additives
410. Bottled drinking water
411. Vitamins and minerals
412. Requirements for Infant Formulas .
14. CHAPTER V. Drugs and Devices
505 is the description of the drug approval process
510(k) is the section that allows for clearance of medical devices
515 is the description of the device approval process.
15. DRUG AND DEVICES
Sections in FDCA gives following information-
505 is the description of the drug approval process
510(k) is the section that allows for clearance of class II medical
devices
515 is the description of the (class III) device approval process.
Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires
those device manufacturers who must register to notify FDA, at least
90 days in advance, of their intent to market a medical device. This is
known as Premarket Notification.
Class I: Devices that do not require premarket approval or clearance but
must follow general controls. Dental floss is a class I device.
Class II: Devices that are cleared using the 510(k) process. Diagnostic
tests, cardiac catheters, and amalgam alloys used to fill cavities are
all class II devices.
Class III: Devices that are approved by the Premarket Approval (PMA)
process, analogous to a New Drug Application. These tend to be
devices that are permanently implanted into a human body or may be
necessary to sustain life
16. CHAPTER VII :
GENERAL ADMINISTRATIVE PROVISIONS
701. Regulations and hearings
702. Examinations and investigations
702a. Seafood inspection
703. Records of interstate shipment
704. Factory inspection
705. Publicity
706. Listing and certification of color additives for foods, drugs, and
cosmetics.
17. CHAPTER VIII :
801.Imports And Exports 8
CHAPTER IX :
901. Miscellaneous
18. LIMITATIONS OF 1938,FOOD DRUG
AND COSMETIC ACT INCLUDES
It did not included drugs which were previously
marketed.
Drugs had to be proven safe but not proven
effective.
The federal govt. had little authority to enact
penalties, if the information on the labels was not
written clearly.
Drugs manufacturer were given the responsibility for
determining whether a drug would be sold as a
prescription or over the counter drug.
Drug manufacturers conducted their own test to
determine drugs effectiveness.
19.
20. Introduction
The Food and Drug Administration (FDA),
established in 1938 as a part of the US Department
of Health and Human Services (HHS), regulates
products accounting for roughly 25% of the US gross
national product.
Major concerns arose with the scandal of birth
defects in European nations caused by
Thalidomide, a drug to be introduced into the US.
The drug was already in use by the pregnant women
in Africa and Europe from 1956-1962 and caused an
estimated 10,000 children born with congenital
deformitiesPhocomelia.).
22. News & Implementation Of
Amendments
Week In FDA History - July
15,1962
Thalidomide, a newly developed
sleeping pill, is found to have
caused birth defects in
thousands of babies born in
Western Europe. News reports
on the role of FDA medical
officer Dr. Frances O. Kelsey in
keeping the drug off the
American market arouse public
support for stronger drug
regulation
23. Week In FDA History - Oct. 10,1962
October 10, 1962:
The Kefauver-Harris
Drug Amendments are
passed, prompted in part
by public concern over
birth defects caused by
the drug thalidomide.
Among the new
requirements: proof of
drug effectiveness as
well as safety, controls
over clinical trials, and
better quality assurance
practices in drug
manufacturing
24. Dr. Francis Kathleen Oldham Kelsey, working for the US FDA
did not want to approve thalidomide into the American drug
market because it was not properly tested as a result of what
was going on in those years.
The KEFAUVER HARRIS AMENDMENT was a response to the
thalidomide tragedy. It was signed by President John F.
Kennedy on October 10, 1962.
US senator Estes Kefauver of the state of Tennessee and
Arkansas state representative Oren Harris required the
American drug manufacturers to present proof of the safety and
effectiveness of their drugs before any endorsements.
Hence, this amendment is also referred to as the DRUG
EFFICACY AMENDMENT.
25.
26. KEFAUVER HARRIS
AMENDMENT
I
N
T
Concerne Controls
R over clinical
O d with
trials and
D proof of
Passed in better QA
U drug
1962 practices in
C effectiven drug
T ess and manufacturi
I safety ng
O
N
27. Objectives Of Amendments
Efficacy was to be established for all drugs since
1938.
Required FDA to assess the efficacy as well as
safety for all drugs products.
First time manufactures were required to prove
effectiveness of drug products prior to marketing.
Gave FDA stricter control over clinical drug trials.
Set GMP to be followed by drug industry.
Regulated advertising.
Kefauver-Harris imposed the efficacy requirement
prior to NDA approval by FDA.
28. APPROVAL OF NEW DRUGS AFTER
IMPLEMENTED OF AMENDMENTS
New drug:
1) safe and effective.
2) approved under NDA procedure a/c
to act at section 505.
IND: for filing IND, form FD-1571,FD-
1572 and FD-1573 are filled.
NDA: Form FD-356.
29.
30. DRUG EFFICACY STUDy
IMPLEMENTATION (DESI)
COLLABORATION
WITH NATIONAL ESTABLISHME
ACADEMY OF NT OF THE
SCIENCE- DESI
NATIONAL PROGRAM IN
RESEARCH 1968
COUNCIL (NAS-
NRC)
It was a retrospective efficacy assessment of drugs
approved prior to 1962.
31. DRUG EFFICACY STUDIES
Early development
In 1966, FDA commissioner approached NAS-NRC to review
already marketed drugs under NDAs approved from 1938-1962.
There were about 300 different medicinal agents.
This was carried out by establishing review committees and a
Policy Advisory Committee whose members were well
acquainted with medical, legal and industrial problems of drugs.
27 and more panels were developed concerning with drugs used
in allergy, anti histaminics, dermatology, anti neoplastics, etc.
Guidelines were established by the advisory committee to review
work of the panels.
By October 1969, the review program was formerly organized and
in operation. The types of products reviewed included single drug
entities or products with two or more entities.
32. DRUG EFFICACY STUDIES
Early development
The panels sought evidence of drug efficacy
from four main sources:
1) Briefs submitted by the sponsor of the drug
2)Additional evidence directly solicited from the
sponsor
3)The files of the FDA
4)Pertinent medical literature brought in by the
panelists.
33. DRUG EFFICACY STUDIES
Effectiveness
categories
EFFECTIVE
Substantial
evidence of
efficacy
INEFFECTI
VE
Insufficient
data
supporting
efficacy
PROBABLY POSSIBLY
EFFECTIVE EFFECTIVE
Needed Research
extra info, needed, max
max time 12 time 6
months months
34. DRUG EFFICACY STUDIES
The conclusions
IMMEDIATE REMOVAL OF PRODUCTS
CURRENTLY MARKETED
RECOGNITION OF CLINICAL STUDIES TO
VERIFY OR ESTABLISH EFFECTIVENESS
UNDER THE NEW LAW
RECOGNITION THAT DIRECTION OR
LABELLING OF CERTAIN PRODUCTS WERE
POORLY ORGANIZED, OUTDATED AND
ORIENTED TO PROMOTION OF PRODUCT
PACKAGE INSERTS NEEDED TO BE
BROUGHT UP TO MODERN STANDARDS
OF ACCURATE AND OBJECTIVE DRUG
INFORMATION.
35. DRUG EFFICACY STUDY
RECORDS
The records of the Drug Efficacy
Study contains:
Correspondence
reports
meeting minutes
press clippings
other records documenting the
activities of the DES.
36. DRUG EFFICACY STUDIES
abbreviated new drug applications
One of the early effects of DESI study was the
development of ANDA.
An Abbreviated New Drug Application (ANDA) is an
application for a U.S. generic drug approval for an existing
licensed medication or approved drug.
The ANDA is submitted to FDA's Center for Drug
Evaluation and Research, Office of Generic Drugs, which
provides for the review and ultimate approval of a generic
drug product. Once approved, an applicant may
manufacture and market the generic drug product to
provide a safe, effective, low cost alternative to the
American public.
A generic drug product is one that is comparable to an
innovator drug product in dosage form, strength, route of
administration, quality, performance characteristics and
intended use. All approved products, both innovator and
generic, are listed in FDA's Approved Drug Products
with Therapeutic Equivalence Evaluations.
37. DRUG EFFICACY STUDIES
abbreviated new drug applications
Generic drug applications are termed "abbreviated"
because they are generally not required to include
preclinical (animal) and clinical (human) data to establish
safety and effectiveness. Instead, generic applicants must
scientifically demonstrate that their product is
bioequivalent (i.e., performs in the same manner as the
innovator drug).
The generic version must deliver the same amount of
active ingredients into a patient's bloodstream in the same
amount of time as the innovator drug.
Using bioequivalence as the basis for approving generic
copies of drug products was established by the Drug Price
Competition and Patent Term Restoration Act of
1984, also known as the HATCH-WAXMAN ACT.
This Act expedites the availability of less costly generic
drugs by permitting FDA to approve applications to market
generic versions of brand-name drugs without conducting
costly and duplicative clinical trials.
38.
39. FLUOROQU
INOLONE
THE BLACK BOX
Tendonitis
(8 july,
REGULATION
2008) On 12 Feb. 1972 FDA promulgated this regulation which
required that the “less than effective” products should be
AVANDIA notified to the practitioner’s by including a statement
(anti prominently in the labeling & surrounding it with an
diabetic) appropriate border.
Heart attack
14
Nov, 2007
It is a type of warning that appears on the package insert
DEPO for prescription drugs that may cause serious adverse
PROVERA effects. It is so named for the black border that usually
Loss of bone surrounds the text of the warning.
density
17 Nov,
2004 It is the strongest warning that the FDA requires.
CELEBREX
(celecoxib)
CV & GI
risk
2002
41. Other FDA REASSESSMENT
PROJECTS
The GRAS List Review of 1969
(review of the safety of all the
food ingredients that had been
included on the Generally
Recognized As Safe List of the late
1950s);
The OTC Drug Review of 1972
(review of the safety and efficacy
of all OTC drugs; and
The Biologics Review of 1972
(review the safety and efficacy of
all biologicals)
42.
43. Other related
legislations
The Medical Device
Amendments of 1976
followed a U.S. Senate
finding that faulty
medical devices had
caused 10,000 injuries,
including 731 deaths. The
law applied safety and
effectiveness safeguards
to new devices.
44. Other related
legislations
2005
Formation of the Drug Safety
Board consisting of FDA staff
and representatives from the
National Institutes of Health and
the Veterans Administration.
The Board will advise the
Director, Center for Drug
Evaluation and Research, FDA,
on drug safety issues.
45. Contd…
DRUG SAFETY AND DRUG EFFICACY:
TWO SIDES OF THE SAME COIN
In 2007, a committee of academic
scientists, research advocates and
representatives of patient community
was convened to recommend ways in
which the Congress and the FDA could
further strengthen product evaluation for
it’s efficacy.
A similar article was also published in the
AACR, in the same year.
46. SAFETY AND EFFICACY
MONITORING
Current scenario
FDA’s
MedWatch
program can
Serious & also be
unexpected approached
side effects for this
NDA sponsors should write to purpose.
submit reports the FDA within
quarterly for 15 days of
first 3 yrs and receipt of info.
annually
afterwards.
47. Impacts of Kefauver Harris
Amendment(1962)
• The Kefauver Harris Amendment strengthened the U.S.
Food and Drug Administration's control of
experimentation on humans.
• It changed the way new drugs are approved and
regulated.
• It introduced a "proof-of-efficacy" requirement, that
was not present before.
• The Amendment required drug advertising to disclose
accurate information about side effects and efficacy of
treatments.
• Cheap generic drugs could no longer be marketed as
expensive drugs under new trade names as new
"breakthrough" medications, as they were prior to the
amendment
48.
49. DRUG EFFICACY STUDY IMPLEMENTATION
The amendment made onerous to evaluate each
product, also to evaluate the active ingredients in
the products. The active ingredients were placed
into one of the three categories.
Category I drugs: those determined to be safe ,
effective, and properly labeled.
Category II drugs: those not generally
recognized as safe and effective, or recognized as
mislabeled; must be removed from medications
within 6 months after the FDA issues its final
regulations.
Category III drugs: those for which data is
insufficient to determine general recognition of
safety and effectiveness.
50. CONCLUSION
Today, the FDA regulates $1 trillion worth
of products a year. It ensures the safety of
all food except for meat, poultry and some
egg products; ensures the safety and
effectiveness of all drugs, biological
products (including blood, vaccines and
tissues for transplantation), medical
devices, and animal drugs and feed; and
makes sure that cosmetics and medical
and consumer products that emit radiation
do no harm.
51. ConClusions …
By 1984, final action had been completed on 3,443
products; - 2,225 were found to be effective, 1,051
were found not effective, and 167 were pending.
52. References
http://www.absoluteastronomy.com/discussion/Drug_Efficacy_Stu
dy_Implementation
http://en.wikipedia.org/wiki/Talk:Drug_Efficacy_Study_Implement
ation
http://www.ssa.gov/OP_Home/comp2/B-CFR-42.html
http://www.nationalacademies.org/ The Drug Efficacy Study of the
National Research Council’s Division of Medical Sciences, 1966-
1969,
W.M. WARDELL, The US Drug Efficacy Study and its Implication
(DESI), Associate Professor, Pharmacology and Toxicology,
University of Rochester, and Director, Center for the Study of Drug
Development, USA
http://edocket.access.gpo.gov/cfr_2008/aprqtr/pdf/21cfr207.20.p
df
W.E. GILBERTSON, The OCT Drug Review - FDA's Viewpoint,
Director Division of OTC Drug Evaluation, Food and Drug
Administration, Rockville, Maryland, USA
Julie B. Esmay, B.S., and Albert I. Wertheimer, Ph.D., A REVIEW OF
OVER-THE-COUNTER DRUG THERAPY, Journal of Community Health
Vol. 5, No. 1, Fall 1979,
53. References
Http://www.Personalcarecouncil.Org/
Http://www.Fda.Gov/drugs/informationondrugs/default.Htm
Http://www.Fda.Gov/drugs/guidancecomplianceregulatoryin
formation/drugregistrationandlisting/default.Htm
Center for veterinary medicine program policy and
procedures manual, guide 1240.3560, General review and
enforcement policies, responsible office: hfv-210,
registration of producers of drugs and listing of drugs in
commercial distribution.
Guidance for industry , providing regulatory submissions in
electronic format – drug establishment registration and drug
listing
Alan h. Kaplan, esq., Fifty years of drug amendments
revisited: in easy-to-swallow capsule form