User Fees for Generic Drugs: A Foregone Conclusion?
Chi, Judy, Drug Topics
Now that user fees appear to be working well for brand-name drug companies, the generic drug industry is toying with the concept.
Under the user-fee system, manufacturers agree to pay the Food & Drug Administration a certain fee per application to enable the agency to hire more staffers to expedite the review of their Abbreviated New Drug Applications (ANDAs).
At the recent National Association of Pharmaceutical Manufacturers' annual meeting, held in Naples, Fla., president Robert Milanese reported that the NAPM's board has decided to negotiate user fees with the FDA and Congress.
Dissatisfied with the speed with which ANDAs are currently approved, NAPM members …
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Publication information: Article title: User Fees for Generic Drugs: A Foregone Conclusion?. Contributors: Chi, Judy - Author. Magazine title: Drug Topics. Volume: 141. Issue: 5 Publication date: March 3, 1997. Page number: 121+. © Advanstar Communications, Inc. Jan 2009. Provided by ProQuest LLC. All Rights Reserved.
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