Biologics License Applications (BLA) Process
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2).
The BLA is regulated under 21 CFR 600 - 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards.
Form 356h specifies the requirements for a BLA. This includes:
- Applicant information
- Product/Manufacturing information
- Pre-clinical studies
- Clinical studies
- Labeling
Featured Products
Best Practices in Quality and Compliance Management
Price: $70.00
Price: $70.00
Immunogenicity To Biologics: Processes, Impact On Efficacy And Safety, and Management Strategy
Processes and effects of immunogenicity to biologics - screening methodologies - regulatory mandates - commercial repercussions of unwanted immune responses
Processes and effects of immunogenicity to biologics - screening methodologies - regulatory mandates - commercial repercussions of unwanted immune responses
Differences in GMP Requirements between Drugs and Biologics
Biologics regulations - drug regulations - differences in GMP requirements
Biologics regulations - drug regulations - differences in GMP requirements
Quality Expectations for Drugs and Biologics during Early Development: Phase 2
Phase 2 FDA Guidance Documents - QC studies - CMC quality elements - Common Technical Document CTD - Biologics License Application BLA - New Drug Application NDA
Phase 2 FDA Guidance Documents - QC studies - CMC quality elements - Common Technical Document CTD - Biologics License Application BLA - New Drug Application NDA
