Structure of FDA

OC, CBER, CDRH, CDER, CFSAN, CTP, CVM, NCTR, ORA

Responsible for efficient and effective implementation of FDA's mission.

Belongs to the Office of Commissioner. Includes:- Office of Combination Products- Office of Good Clinical Practice- Office of Orphan Product Development-Office of Pediatric Therapeutics

Evaluates new prescriptions and OTC drugs. Monitors tv, radio and print adds. Oversight:- small molecule drugs-therapeutic biologics -monoclonal antibodies -cytokines -growth factors -enzymes and interferons(including recombinant versions) -proteins intended for therapeutic use derived from animals or microoganisms. -therapeutic immunotherapies

Regulates biological products for prevention and treatment. Oversight:-vaccines-blood products-plasma expanders-gene therapy-products composed of human or animal cells or cells parts-allergen patch tests allergenic extracts-antitoxins-antivenins-venoms-in vitro diagnostics-toxoids/toxins intended for immunization

-medical devices-radiation-emitting products (microwaves, cell phones, tvs, lasers)-monitors the products throughout the product lifecycle, including post market

-animal food products are safe.-food and drugs given to animals

-safety of almost all food consumed in the US, except meat, poultry and some egg products.

Conducts research and provides advice and training necessary for science based decision making and developing sound regulatory policy.

Overseeing the implementation of the Family Smoking Prevention and Tobacco Control Act , which became law on 22 June 2009.

-Advises and assits on regulations and compliance matters. -Evaluates and coordinates all proposed FDA legal actions to ascertain compliance with regulatory policy.

1906Prohibited the interstate transport of unlawful food and drugs under penalty of seizure of questionable products and/or prosecution of responsible parties.The basis of the law rested on labeling rather than premarket approval.

1938Replaced the 1906 act and revised the misbranding standard.Introduce premarket drug review.Cosmetic and medical devices under FDA control.

Revised in 1912, stated that a drug was misbranded if its label contained a "false and fraudulent" statement regarding "curative or therapeutic effect".

1951 - clarified what constituted a prescription vs an OTC.