User Fees For Faster Drug Reviews.(Food and Drug Administration is better prepared to handle novel drug reviews)

From: FDA Consumer | Date: September 1, 2000| Author: Thompson, Larry | Copyright information

Are They Helping Or Hurting The Public Health?

A DECADE AGO, the Food and Drug Administration was an obstacle to the delivery of novel drugs to patients because its drug review activities were under-funded and the staff couldn't review products in a timely way. The review of New Drug Applications, the so-called NDAs that companies file on all new pharmaceuticals they want to market, took unacceptably long to process--about two-and-a-half years.

Today, FDA staf...

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