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CNN Live At Daybreak

Ask CNN: Who Decides When a New Drug is Approved for Distribution?

Aired July 23, 2001 - 07:36   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
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ANNOUNCER: Jordanna McCormick from Guelph, Ontario, asks: Who decides when a new drug is approved for distribution? And is there a mandatory time period for testing prior to approval?

DR. SAUNDRA KWEDER, ACTING DIRECTOR, OFFICE OF REVIEW MANAGEMENT FDA: The FDA is charged under the Food, Drug and Cosmetic Act with making regulatory decisions about when a drug can be marketed by a company. In order to be marketed, the decision that is made has more to do with whether or not standards have been met for demonstrating that the drug is safe for its intended use and effective for its intended use and much less to do with how long the drug has been under study. Some drugs, to demonstrate safety and efficacy, undergo studies that span a period of several years. It's unique for every product.

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