Healthy Skepticism Library item: 8189

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Publication type: Journal Article

McCann B.
How will FDA reform affect the generic industry?
Drug Topics 1997 Nov; 141:

Abstract:

The ways in which the U.S. Food and Drug Administration (FDA) reforms will affect the generic industry are described, including the reauthorization of the Prescription Drug User Fee Act , which allows brand manufacturers to pay the FDA a fee so it can hire more staff to expedite the review of new drug applications, the provision of the bill that grants 6 months of marketing exclusivity to brand manufacturers who conduct pediatric studies, the possibility of exclusivity being granted to branded antibiotics, and the lack of impact of FDA legislation on citizen petitions that delay the introduction of generic drugs into the market.