The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...
Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review their AVTO6 ...
The cuts hit the FDA’s medical device center particularly hard, impacting product reviewers and researchers of AI-enabled medical technology. Notably, the center has a strained relationship with one ...
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