FDA: Inspection Lag Puts Generic Drug Exclusivity At Risk

By Kelly Lienhard / April 8, 2021 at 1:43 PM
In its latest guidance for the generic drug industry, FDA indicates that due to the backlog of onsite facility inspections, some generic drug makers might not be able to meet requirements for tentative approval for their drugs and as a result might not qualify for 180-day exclusivity, which raises questions about whether FDA will use its authority to disqualify companies from exclusivity, and if so, how the agency would decide which companies qualify and which don’t. While some sources said...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.