
FDA Issues Guidance on Bioresearch Monitoring Content for NDAs and BLAs
The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.
FDA published
The draft guidance addresses the submission of clinical study-level information, subject-level data line listings, and summary-level clinical site dataset. The information must be submitted with NDAs, BLAs, and supplement applications electronically using FDA’s Electronic Submission Gateway or by using appropriate physical media. The new draft guidance supersedes previously issued draft guidance.
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