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ANDAs By The Numbers: Metrics Look Good – But Review Processes Need Attention Too

 
• By Cole Werble

US FDA is approving generics at record pace, providing important statistics to support efforts by Commissioner Gottlieb to position the agency as part of the solution to concerns about high drug prices; new guidance for industry and FDA reviewers, however, suggests there is still a need for more rigor in preparing and assessing submissions.

The US FDA is duly proud of its recent ANDA approval metrics: 171 approvals and 37 tentative approvals in the first two months of fiscal 2018 (October and November 2017).

Commissioner Scott Gottlieb touted the higher number of approvals in a Jan. 3 statement that pointed to November’s...

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More from Biosimilars & Generics

Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
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US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.