Senate Health Committee Plans To Codify FDA Generic Drug Proposal
This article was originally published in The Tan Sheet
The Senate Health & Education Committee plans to codify FDA's Hatch/Waxman reform proposal after the final rule is issued
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Legislation to reform the generic drug approval process will still be needed following issuance of FDA's final rule, Sens. John McCain (R-Ariz.) and Charles Schumer (D-N.Y.) said
FDA's proposal to allow only one 30-month stay of approval for ANDAs hinges on a reinterpretation of Hatch/Waxman language declaring that patent holders must be notified if a generic application is amended to "include" a Paragraph IV certification
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