usfda
TRANSCRIPT
Let’s Learn about
Sahil Khatter
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.
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)
FDA Organizations
FDA regulat
es
Cosmetics
Drugs
Foods
Medical
Devices
Radiation
emitting
electronic
products
Veterinary
products
Biologics
FDA Functions-
Landmarks In Regulations
Food and Drug Act 1906
Federal Food, Drug and
Cosmetic Act 1938
Durham-Humphrey
Amendments 1951
Hatch-Waxman Act 1984
Comprehensive Drug Abuse
Prevention and Control Act 1970
Prescription Drug User Fee Act
1992
Drug Safety Board 2005
Kefauver-Harris Drug
Amendments 1962
Hatch-Waxman Act 1984
Provides centralized agency-wide program direction and management services to support effective administration and FDA's consumer protection efforts within its regulatory framework and to put available resources to the most efficient use.
Office of the Commissioner
Acts as consumer watchdog in America’s healthcare system.
Oversees the research, development, manufacture and marketing of drugs.
Ensures safety and efficacy of available drugs.
Regulates: Prescription drugs Generic drugs OTC drugs
Also ensures truth in advertising for prescription drugs.
Center For Drug Evaluation and Research
Center for Biologics evaluation and Research(CBER)
Center For Food Security and Applied Nutrition
Radiation
Ionizing X-ray
e.g. Dental radiography, Industrial X-ray etc.
Optical(visible, UV,IR,laser )
e.g. Surgical laser, Germicide lamp etc.
RF, Microwave, magnetic
e.g. MRI, Microwave oven etc.
Acoustic(ultrasonic)
e.g.Ultrasonography,Hearing aids etc.
CDRH Controls over
CENTER FOR VETERINARY MEDICINERegulates food, food additives, and drugs that are given to animals(food animals, pets)
Primary focus –1.on medications that are used in food animals, and2. assurance that they don’t affect human food supply
Restricts the spread of bovine spongiform encephalopathy by doing inspections of feed manufacturers
National Center for toxicological Research(NCTR)
Research arm of FDA
The research at NCTR supports FDA’s goals: 1) to understand critical biological events in the
expression of toxicity, 2) to develop and characterize methods, and
incorporate new technologies to improve the assessment of human exposure, susceptibility, and risk, and
3) to increase the understanding of the interaction between genetics, metabolism, and nutrition.
ORA mission is to enhance public health by implementing FDA regulations and minimizing the risks associated with the products
Office Of Regulatory Affairs
FDA’s Office of Criminal Investigations (OCI) is an integral part of FDA’s mission to protect the public’s health. Top-flight special agents –who have investigative authority similar to other federal
law enforcement agencies – give the FDA unique fact-finding tools and provide for strong, industry-wide deterrence. Their
work is different from, but enhances, the regulatory inspectors and investigators that make up the bulk of FDA’s field
operations. -
Office Of Criminal Investigation