usfda sana 1
TRANSCRIPT
school of pharmaceutical science (sops, utd-rgpv, Bhopal (m.p.)
Prepared By-Sana iram
M.PHARM (Q.A)1st sem.
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
Formed 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
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.
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
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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
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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
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FDA regulates interstate commerce Transparency Same standards for domestic and
international Science-based regulations Consistency and predictability of
implementation
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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)
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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.
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)
Component Full Form RegulatesCBER Center For Biologics Evaluation
And ResearchBiological 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.
Food Drugs Medical Devices * Biologics Animal Feed and Drugs Cosmetics Radiation-Emitting
Products * Combination Products
(drug-device*, biologic-device*, drug-biologic)
CDER Center for Drugs andEvaluation Research
CVMCenter for
Veterinary Medicine
NCTRNational Center
for Toxicological Research
CFSANCenter for Food Safetyand Applied Nutrition
CBER Center for Biologics and
Evaluation Research
CDRHCenter for Devices
and Radiological Health
FDA
*
Enabling Enabling TechnologyTechnology
and Innovationand Innovation
Enabling Enabling TechnologyTechnology
and Innovationand Innovation
Efficient, Efficient, Effective, Effective,
and Predictable and Predictable Product Product
DevelopmentDevelopment
Efficient, Efficient, Effective, Effective,
and Predictable and Predictable Product Product
DevelopmentDevelopment
Ensuring Ensuring the Safety ofthe Safety of Marketed Marketed
Medical DevicesMedical Devices
Ensuring Ensuring the Safety ofthe Safety of Marketed Marketed
Medical DevicesMedical Devices
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
◦ 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
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
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
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
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.
Development
Discovery Development
Approximately 10–15 years from idea to marketable drug
Preclinical studies Clinical studies
CHEMISTRY/ PHARMA-COLOGY
IND* PHASE I PHASE II PHASE III NDA** PHASE IV
Search for active
substances
Toxicology, efficacy
studies on various types of animals
Regulatory review
Efficacy studies on
healthy volunteers
Clinical studies on a limited scale
Comparative studies on a large number of patients
Regulatory review
Continued comparative studies*Investigational
New DrugApplication for permission to
administer a new drug to humans
50–150persons
100–200patients
500–5,000patients
Registration, market
introduction
**New Drug Application
Application for permission to market
a new drug
KNOWLEDGE
LEVEL
KNOWLEDGE
LEVEL
2–4 yrs. 2–6 months 3–6 yrs. 1–3 yrs.
TIME SPAN
Early Clinical
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(NDA) Requirements (ANDA) Requirements 1. Labeling 1. Labeling2. Pharm / Tox 2. Pharm / Tox3. Chemistry 3. Chemistry4. Manufacturing 4. Manufacturing5. Controls 5. Controls6. Microbiology 6. Microbiology7. Inspection 7. Inspection8. Testing 8. Testing9. Animal Studies10. Clinical Studies 9. Bioequivalence11. 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)
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
Source: Newport Horizon Premium™
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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1. Drugs and Cosmetic Act, 1940, Govt. of India
2. Drugs and Cosmetic Rules, 1945, Govt. of India.
3. Office of Generic Drugs Home Page: ttp://www.fda.gov/cder/ogd/index.htm
4. On line training program: http://www.fda.gov/cder/learn/CDERLearn/gen DrugProcess/transcript.htm
5. http://www.fda.gov/cder/orange/default.htm
6. www.cdsco.nic.in