This document provides an overview of the US Food and Drug Administration (FDA) in 3 paragraphs. It discusses that the FDA was formed in 1906 and is responsible for regulating foods, drugs, medical devices, and other products. It describes the FDA's structure and responsibilities across its centers and offices. The document also provides brief summaries of the FDA approval processes for drugs, medical devices, and food products.
USFDA Regulations and Guidelines for Pharmaceutical Products
1. school of pharmaceutical science
(sops, utd-rgpv, Bhopal (m.p.)
Prepared Bysana iram
M.PHARM (Q.A)
1st sem.
2.
Mission, vision and organistional structure of USFDA
U.S Federal partners
Responsibility
Act and Regulations
Overview of guidelines
R & D process
IND, NDA and ANDA
US FDA preperation
References
3.
Formed
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1906
Preceding agencies
Food, Drug, and Insecticide Administration (July 1927 to July 1930)
Bureau of Chemistry, USDA (July 1901 through July 1927)
Division of Chemistry, USDA (established 1862)
Jurisdiction
Federal government of the United States
Headquarters
White Oak Campus, 10903 New Hampshire Avenue, Silver Spring,
Maryland 20993 39°02′07″N 76°58′59″W
Employees
9,300
Annual budget
$4.36 billion
Agency executive
Dr. Margaret Hamburg, Commissioner of Food and Drugs
[3]
Parent Agency
Department of Health and Human Services
Child agencies
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Center for Food Safety and Applied Nutrition
Center for Tobacco Products
Center for Veterinary Medicine
National Center for Toxicological Research
Office of Criminal Investigations
Office of Regulatory Affairs
Website
www.fda.gov
Laboratories Thirteen
States
Fifty
4.
The Food and Drug Administration (FDA or
USFDA) is an agency of the United States
Department of Health and Human Services
and is responsible for regulating and
supervising the safety of foods, dietary
supplements, drugs, vaccines, biological
medical products, blood products, medical
devices, radiation-emitting devices,
veterinary products, and cosmetics.
5. 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
1962 – Food, Drug, and Cosmetics Act
Amendments
1966 – Fair Packaging and Labeling Act
1976 – Medical Device Regulation Act
1987 – Prescription Drug Marketing Act
5
6. 1988 – Anti–drug Abuse Act
1990 – Nutrition Labeling and Education Act
1992 – Prescription Drug User Fee Act
1994 – Dietary Supplement Health and
Education Act
1997 – Food and Drug 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
6
7.
Public demands action
Congress enacts general law
FDA proposes science-based regulations to put the law
into effect
Regulations are notified, finalized and published in 21
Code of Federal Regulations (CFR)
FDA assures compliance by enforcement and inspections
that are targeted by risk assessment
Industry has the ultimate responsibility to produce safe
foods
7
8. FDA regulates interstate commerce
Transparency
Same standards for domestic and international
Science-based regulations
Consistency and predictability of implementation
8
9. Department of Health and Human Services (HHS)
◦ Food and Drug Administration (FDA)
◦ Centers for Disease Control and Prevention (CDC)
Department of Agriculture (USDA)
◦ Food Safety and Inspection Service (FSIS)
◦ Animal and Plant Health Inspection Service (APHIS)
◦ Foreign Agricultural Service (FAS)
Environmental Protection Agency (EPA)
Bureau of Customs and Border Protection (CBP)
Alcohol and Tobacco Tax and Trade Bureau (TTB)
9
10.
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
Advancing the public health by helping to speed product
innovations
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.
11.
The Office of the Commissioner (OC)
The Center for Drug Evaluation and Research (CDER)
The Center for Biologics Evaluation and Research (CBER)
The Center for Food Safety and Applied Nutrition (CFSAN)
The Center for Devices and Radiological Health (CDRH)
The Center for Veterinary Medicine (CVM)
The National Center for Toxicological Research (NCTR)
The Office of Regulatory Affairs (ORA)
The Office of Criminal Investigations (OCI)
12. Component
Full Form
Regulates
CBER
Center For Biologics Evaluation
And Research
Biological Products.
CDRH
Center For Devices And
Radiological Health
Safety and Effectiveness of New
Medical Devices Before Marketed.
CDER
Center For Drug Evaluation And
Research
Health of by Assuring Prescription
and OTC Drugs are Safe and
Effective.
CSFAN
Center For Food Safety And
Applied Nutrition
Food Supply is Safe, Sanitary,
Wholesome, and Honestly Labeled, and
Cosmetic Products are Safe and
Properly Labeled.
CVM
Center For Veterinary Medicine
Assure that Animal Food Products
are Safe.
NCTR
National Center For Toxicological
Research
Human Toxicity.
OC
Office Of The Commissioner
………………
ORA
Office Of Regulatory Affairs
Products Comply with Appropriate Public
Health Laws and Regulations.
13.
Food
Drugs
Medical Devices *
Biologics
Animal Feed and Drugs
Cosmetics
Radiation-Emitting
Products *
Combination Products
(drug-device*, biologicdevice*, drug-biologic)
*
CDRH
Center for Devices
and Radiological Health
CDER
Center for Drugs and
Evaluation Research
CBER
Center for Biologics and
Evaluation Research
FDA
CVM
Center for
Veterinary Medicine
CFSAN
Center for Food Safety
and Applied Nutrition
NCTR
National Center
for Toxicological Research
15.
Foods
◦ safety of all food products
(except for most meat and poultry products, which are regulated by the
U.S. Department of Agriculture)
◦ labeling
◦ bottled water
◦ food additives
◦ infant formulas
Dietary Supplements
Human Drugs
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◦
product approvals
OTC and prescription drug labeling
drug manufacturing standards
Vaccines, Blood Products, and Other Biologics
product and manufacturing establishment licensing
safety of the nation's blood supply
research to establish product standards and develop improved testing
methods
16.
Medical Devices
from simple items like tongue depressors, to complex technologies such as heart
pacemakers
premarket approval of new devices
manufacturing and performance standards
tracking reports of device malfunctioning and serious adverse reactions
Electronic Products
products that give off radiation, such as microwave ovens and X-ray equipment
radiation safety performance standards for microwave ovens, television receivers,
diagnostic
x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser
products,
ultrasonic therapy equipment, mercury vapor lamps, and sunlamps
accrediting and inspecting mammography facilities
Cosmetics
safety
labeling
Veterinary Products
livestock feeds
pet foods
veterinary drugs and devices
veterinary biologics not regulated by USDA are considered new animal drugs
Tobacco Products
17. CFR Title 21 (Code Of Federal Regulation)
- Food and Drugs: Parts 1 to 1499 different
types of parts to food, drug , cosmetic and
medical devices and etc
For Conducting a clinical research on IND
different imp parts is their
18. 21 CFR part 11- Electronic submission and Electronic
signature
21 CFR part 50- Protection of human subjects
21 CFR part 54- Financial Disclosure by Clinical
Investigators
21 CFR part 56- Institutional Review Board
21 CFR part 312- Investigational new drug application
21 CFR part 314- Application for FDA Approval to
Market a New Drug
19.
20. Foods are safe, wholesome and sanitary;
Human and veterinary drugs and medical
devices are safe and effective;
Human biologics are safe and effective;
Cosmetics are safe;
Electronic products that emit radiation are safe;
and
Labeling for these products honestly represents
them to users, and their instructions for use are
adequate.
21. Development
Preclinical studies
Early Clinical
Development
CHEMISTRY/
PHARMACOLOGY
IND*
PHASE I
PHASE II
PHASE III
NDA**
PHASE IV
Search for
active
substances
Regulatory
review
Efficacy
studies on
healthy
volunteers
Clinical
studies on a
limited scale
Regulatory
review
Continued
comparative
studies
50–150
persons
100–200
patients
Comparativ
e studies on
a large
number of
patients
20/12/13
Discovery
Clinical studies
*Investigational
New Drug
Application for
permission to
administer a new
drug to humans
Toxicology,
efficacy
studies on
various types
of animals KNOWLEDGE
LEVEL
500–5,000
patients
LEVEL
KNOWLEDGE
Registration,
market
introduction
**New Drug
Application
Application for
permission to market
a new drug
TIME SPAN
2–4 yrs.
2–6 months
3–6 yrs.
1–3 yrs.
Approximately 10–15 years from idea to marketable drug
21
22.
23.
24. (NDA) Requirements
(ANDA) Requirements
1. Labeling
1. Labeling
2. Pharm / Tox
2. Pharm / Tox
3. Chemistry 3. Chemistry
4. Manufacturing
4. Manufacturing
5. Controls
5. Controls
6. Microbiology
6. Microbiology
7. Inspection 7. Inspection
8. Testing
8. Testing
9. Animal Studies
10. Clinical Studies
9. Bioequivalence
11. Bioavailability
Labeling
◦ “Same” information as brand name labeling
◦ May delete portions of labeling protected by patent or exclusivity (i.e., an
indication, strength)
◦ May differ in excipients and product description (i.e., colors, shapes)
25.
FDA inspects manufacturers or processors of FDA-regulated products
to verify that they comply with relevant regulations. Those inspected
include
vaccine and drug manufacturers
blood banks
food processing facilities
dairy farms
animal feed processors
FDA also inspects
facilities that conduct studies in people (clinical trials)
laboratories that conduct studies in animals or microorganisms when
these studies are used to apply for FDA approval of a medical product
foreign manufacturing and processing sites for FDA-regulated products
that are sold in the United States
imported products at the border
31.
Register facility with FDA
Register process for canning/aseptic packaging of
Low Acid/Acidified Canned Foods (LACF)
Use good practices in food production
◦ Agricultural
◦ Aquacultural
◦ Manufacturing
◦ HACCP
Assure that the product is safe, wholesome, sanitary,
properly packaged and labeled
Give “Prior Notice”
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32. 1.
2.
3.
4.
5.
6.
Drugs and Cosmetic Act, 1940, Govt. of India
Drugs and Cosmetic Rules, 1945, Govt. of
India.
Office of Generic Drugs Home Page:
ttp://www.fda.gov/cder/ogd/index.htm
On line training program:
http://www.fda.gov/cder/learn/CDERLearn/gen
DrugProcess/transcript.htm
http://www.fda.gov/cder/orange/default.htm
www.cdsco.nic.in
Hinweis der Redaktion
Origins
The U S. Food and Drug Administration is a scientific, regulatory, and public health agency that oversees items accounting for 25 cents of every dollar spent by consumers. Its jurisdiction encompasses most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed. The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 9,100 employees and a budget of $1.294 billion in 2001, comprising chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, and many others. About one-third of the agency's employees are stationed outside of the Washington, D. C. area, staffing over 150 field offices and laboratories, including five regional offices and 20 district offices. Agency scientists evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs. Also, the FDA monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person. Investigators and inspectors visit more than 16,000 facilities a year, and arrange with state governments to help increase the number of facilities checked.
HISTORY
The legislation having failed to develop, the Secretary of HEW commissioned the Study Group on Medical Devices, which recommended in 1970 that medical devices be classified according to their comparative risk, and regulated accordingly. The 1976 Medical Device Amendments, coming on the heels of a therapeutic disaster in which thousands of women were injured by the Dalkon Shield intrauterine device, provided for three classes of medical devices, each requiring a different level of regulatory scrutiny--up to pre-market approval.
1976
MEDICAL DEVICE AMENDMENTS passed to ensure safety and effectiveness of medical devices, including diagnostic products. The amendments require manufacturers to register with FDA and follow quality control procedures. Some products must have pre-market approval by FDA; others must meet performance standards before marketing.
TOTAL PRODUCT LIFE CYCLE MODEL (TPLC) is applied across Center activities to promote and protect the public heath.
Total Product Life Cycle (TPLC) is an integrated product development scheme and a conceptual framework for assessing a variety of industrial and clinical models. For the manufacturer TPLC is the market-driven evolution of a device, drug, or biologic from initial conception, through pre-market development, to widespread market use, and finally to obsolescence and replacement by subsequent generations of products.
There are various ways of illustrating the R&D process – this is one. We see, among other things, how knowledge about a drug increases during the course of the process, but that upon market introduction, there is still a great deal to be learned about how the drug works in the body. Developing a new drug is a complex and costly process.
If everything goes according to plan, a new drug will be ready approximately ten years after the work was first begun. We are working to shorten this time to eight years.
Pharmaceutical companies are constantly striving to shorten the time from idea to finished pharmaceutical product. At the same time, the demands on documentation continue to rise.
Lets look at where these inspections have taken place. Almost a third of them have been in the U.S., which makes sense. But there is also plenty of presence by the FDA in India, Italy, and China and that is expected to increase over coming years.