PDUFA III Or Hatch/Waxman II?: Payors Urge Fix For Generic “Loopholes”
This article was originally published in The Tan Sheet
Executive Summary
Supporters of the generic industry's Hatch/Waxman agenda are eyeing the Prescription Drug User Fee Act reauthorization as a potential vehicle for reform measures
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The FDA/industry PDUFA III agreement includes funding to expand FDA's Office of Drug Safety by 100 full-time equivalent staff positions over five years
PDUFA III Deal Includes Risk Management Fees In “Peri-Approval” Phase
The FDA/industry PDUFA III agreement includes funding to expand FDA's Office of Drug Safety by 100 full-time equivalent staff positions over five years