FDA Antimicrobial Development Draft Guidances Withdrawn Under Rejuvenation Initiative
This article was originally published in The Pink Sheet Daily
FDA says the 13 guidances are out of date and of no use to industry; a number of others covering various topics also will be revised or finalized.
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FDA’s Center for Drug Evaluation and Research plans to publish more than 50 new and revised draft guidances this calendar year.
Sotagliflozin Hail Mary? Lexicon Seeks Opportunity For Formal Hearing On FDA Intent To Deny Approval
After complete response letter, Lexicon triggers rarely used mechanism for formal hearing, prompting US FDA to publicly list its problems with the proposed type 1 diabetes drug, for which Sanofi had originally sought approval.
As agency implements testing program for its staff, sponsors are drawing up protocols to ensure inspector safety and forwarding them to FDA, but still can’t trigger an inspection.