FDA NDA Review Packet for PIVMECILLINAM Including Medical and Chemistry Reviews

FDA NDA Review Packet for PIVMECILLINAM Including Medical and Chemistry Reviews

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Original Request: Request PDF file of PIVMECILLINAM NDA review packet discussing medical reviews, chemistry review, pharmacology reviews, microbiology reviews, clinical pharmacology biopharmaceutics reviews, etc. Information usually found on Drugs@FDA but currently not available. Unable to locate FDA meeting agenda for committee or subcommittee discussion and approval was held. Purpose is to further assess and evaluate medication information for scientific and health care review/publication.
Tags: Pharma, NDA, 2024
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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