Lexology June 17, 2024
Welcome to , designed to help you identify significant legal developments and navigate the evolving business, legal, and regulatory world.
Two draft guidance documents on bioresearch monitoring.
- On June 4, 2024, FDA’s Center for Biologics Evaluation and Research (CBER) issued two draft guidance documents on bioresearch monitoring (BIMO), “Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions” and “Processes and Practices Applicable to Bioresearch Monitoring Inspections.”
- The first draft guidance, when finalized, will provide additional information regarding the format to be used for electronic submission of biologics license applications (BLA), new drug applications (NDA), and certain supplemental application content for planning and conducting...
Today's Sponsors
Today's Sponsor