Food and Drug Administration (FDA) is the oldest federal agency dedicated to consumer protection. FDA is a scientific, regulatory, and public health agency that oversees almost any food, cosmetic, drug, radiation product, medical device or biologic product you can think of.

Although it was not known by its present name until 1930, FDA’s modern regulatory functions began in 1906 after the Pure Food and Drugs Act was passed. The Pure Food and Drugs Act was a law that prohibited interstate commerce in adulterated and misbranded food and drugs.

Inside the FDA

The FDA provides oversight for clinical trials that use FDA regulated products and human subjects. Most human medical products, including biologics, drugs and devices are regulated by three FDA centers:

Center for Biologics Evaluation and Research (CBER)

CBER includes Offices for Therapeutics; Vaccines; Blood; Cell; Tissue, and Gene Therapy.  CBER regulates biological products for human use. Biological products are categorized into

• Blood & blood products
• Cellular & gene therapy products
• Tissue & tissue products
• Vaccines
• Xenotransplantation

Center for Drugs Evaluation and Research (CDER)

CDER regulates drugs to ensure safety and efficacy to public health. Some of the products regulated by CDER include:

• Over-the-counter drugs
• Prescription drugs, including biological therapeutics (proteins, antibodies, etc.) and generic drugs
• Other medical products (fluoride toothpaste, antiperspirants, dandruff shampoos, sunscreens, etc.)

Center for Devices and Radiological Health (CDRH)

CDRH regulates medical devices, in-vitro diagnostics, and radiation emitting products such as lasers, x-ray systems, cellular phones, and microwave ovens.

Other major divisions of the FDA include:

• Center for Food Safety and Applied Nutrition (CFSAN)
• Center for Veterinary Medicine (CVM)
• National Center for Toxicological Research (NCTR)
• Office of the Commissioner (OC)
• Office of Regulatory Affairs (ORA)

FDA Regulations

FDA regulations are published in title 21 of the CFR. FDA’s human subject protection regulations include:

• 21 CFR part 50, Protection of Human Subjects – which delineates requirements for informed consent was issued in 1980, revised in 1981, 1989, 1990, 1991, 1996, 1997, 1999, and 2006
• Subpart D Protections for Children – was added to 21 CFR part 50 in 2001
• 21 CFR part 54, Financial Disclosure by Clinical Investigators
• 21 CFR part 56, Institutional Review Boards – was issued in 1981 and revised in 1989, 1991, 1999, 2000, 2001, 2002, and 2009
• 21 CFR part 312, Investigational New Drug Application
• 21 CFR part 812, Investigational Device Exemptions

FDA Guidance

FDA guidance provides FDA’s expectation to the industry in the development of a drug, biologic, medical device, or in vitro diagnostic test. Guidance is not a law or a regulation. Thus, using a method of testing other than in the guidance may be acceptable to the FDA. However, consultation with the FDA is generally a good approach to ensure that mutual agreements are in place prior to the start of testing.

FDA Website and Important Links

Official FDA Web site – http://www.fda.gov/

Guidance documents

Biologics: http://www.fda.gov/cber/guidelines.htm

Drugs: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Devices: http://www.fda.gov/cdrh/guidance.html

Information for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors – http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm

IND – http://www.fda.gov/cber/ind/ind.htm

Related pages

1. Country Specific Regulations – Global / International Trial
2. European Medicines Agency (EMA)
3. Historical Events behind Current Regulations
4. ICH’s GCP Guideline