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Here are the recurring topics that keep showing up across pharma manufacturing sites: Inadequate response to Form 483 observations FDA findings A surprising number of organizations waste their 15-day response window by sending generic statements

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Guidance Documents Now Available: New recorded webinar on FDAs recently published guidance, Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application (BLA) Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs Topical Dermatologic Corticosteroids: In Vivo Bioequivalence Psychedelic Drugs: Considerations for Clinical Investigations View all Official FDA Guidance Documents and other Regulatory Guidance You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period