BioPhorum’s in-depth feedback includes 70 line-by-line, detailed comments, including the rationale for the points and any proposed changes/recommendations that are deemed necessary by the team to ensure a harmonized implementation across industry and regulatory agencies.
Biologics License Applications
Viewing related articles
Referencing licence applications
Apr 2022 | Benchmarking, Deliverable, Deliverables Report, Development Group
A BioPhorum member resource which captures journal or paper articles that BioPhorum members have successfully used in their clinical and license applications. The database captures: Process Stage Purpose Reference - submission section Paper Reference Comments The tool is available for members to use and the Phorum is encouraging their workstreams to add to it. DG hopes to see this list grow and become a useful resource to...
Clinically relevant specifications setting benchmarking survey
Mar 2022 | Accelerate CMC Development to Marketing Application, Benchmarking, CMC Regulatory, Deliverable, Deliverables Report, Development Group
A BioPhorum member only survey gathering feedback on initial submission Biologics License Applications (BLA) / Marketing Authorization Application (MAA) supplement/variation, etc.) and the outcome of health authority review and approval of the submission.