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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/04

/23

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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