FDA Breaks Record On Approvals
FDA Reports 1,171 Generic Drug Approvals In Fiscal 2019
As the FDA breaks its record for generic drug approvals in fiscal year 2019, it emphasizes the importance of consumer confidence in the safety and quality of approved generics.
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The April total is the highest monthly total in seven months, but only a few are first generics. Approval volume might continue rising if FDA does not find too many applications requiring in-person inspections, which were largely postponed as part of coronavirus containment measures, Robert Pollock, senior advisor and outside director to the board at Lachman Consultants, said.
US FDA reports another low tally of full approvals in October, but stakeholders are not worried given the agency's history of record-breaking totals year over year.
The AAM has commended the FDA’s efforts on identifying the root causes of drug shortages in 2019 and has committed to work with the agency in pursuit of a “healthy, sustainable market for safe, effective and affordable medicines for patients.”