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Porphyria Educational Services

Vol. 2 No. 27                                                                    
July 2, 2000
      FOCUS:   FDA = Food and Drug Administration

When did the FDA start?
Prior to 1931 the FDA was named the Food, Drug and Insecticide Administration.

What is the FDA?
The FDA is the federal agency which regulates the food we eat and the medicines, medical devices, cosmetics and radition-emitting products that we use.
The purpose is to help ensure safety, effectiveness and proper product labeling.
Feed and drugs for pets and farm animals are also included within its jurisdiction.

What is the role of the FDA in clinical trials?
The FDA's 2100 scientists review tests results submitted by the developers of all medications and medical devices to determine whether clinical trials are warranted. Addiitonally the FDA approves the action plan [ known as the protocol] and the team of researchers sele ted to conduct the research.
Final approval by the FDA, post-trials, determines whether the product can be made available to the public.

How long does it take a new medication to receive FDA approval?
Taking into account early lab testing [pre=FDA approval], completion of the clinical trial-phases and a review, the average time to get a new product approved is eight and one-half years.

What happens after FDA approval?
Upon final FDA approval, the product can be placed on the market. Usually another set of studies will take place. Further studies on sel;ect patients are conducted to collect safety data and confirm clinical benefits. Over the lifetime of a product, reporting and inspections are reviewed by the FDA.