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USA: FDA Issues Guidance on Bioresearch Monitoring Content for NDAs and BLAs

Wednesday, February 21, 2018: The US Food and Drug Administration (FDA) has published draft guidance detailing the electronic submission of data and information from studies used to support the safety and efficacy claims in new drug applications (NDAs) and biologics license applications (BLAs), as well as supplemental applications containing new clinical study reports and certain investigational new drug applications. The agency’s Center for Drug Evaluation and Research (CDER) uses such data to identify sites for FDA inspections plan for bioresearch monitoring (BIMO). FDA states in the guidance that these types of data must be submitted electronically in the specified format, effective 24 months after the final guidance is issued.

The draft guidance addresses the submission of clinical study-level information, subject-level data line listings, and summary-level clinical site dataset.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 The new draft guidance supersedes previously issued draft guidance.

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