CDER BIMO: Electronic Submission Requirements for New Drug and Biologic Licensing Applications

The Food and Drug Administration issued the final guidance for industry entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions.” This guidance describes the electronic submission of certain data and information in standardized formats that FDA uses to plan bioresearch monitoring (BIMO) inspections, to facilitate the timely identification of sites for inspection, and to ensure that field investigators from the Agency have the information needed to conduct the inspections.

The submissions described in the final guidance will be required 24 months after the guidance issued. As a result of this webinar, sponsors and/or applicants planning to submit new drug applications (NDAs), biologics license applications (BLAs) and NDA or BLA supplements containing new clinical study reports to CDER will understand the information they will be required to submit.

Timestamps

00:17 – CDER Bioresearch Monitoring (BIMO) Requests for New Drug and Biologic Licensing Applications

05:26 – Standardized Format for Electronic Submission of NDA and BLA Content for BIMO Inspections
for CDER Submissions

Speakers:

Laurie Muldowney, MD
Deputy Director
Office of Scientific Investigations (OSI)
CDER | FDA

Stephanie Coquia, MD
Senior Physician
Division of Clinical Compliance Evaluation (DCCE)
OSI | CDER | FDA

Learn more at: (Need event webpage URL once it is created and published)

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YouTube Tags (Keywords)
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