Description
In the Federal Register of July 8, 1997 (62 FR 36558), the Food and Drug Administration (FDA) announced the availability of the revised Form FDA 356h, Biologics License Application (BLA) entitled Application to Market a New Drug, Biologic, or an Antibiotic for Human Use. This document provides guidance on the content and format of the Chemistry, Manufacturing and Controls (CMC) section and the EstablishmentDescription section of a Biologics License Application for a Human Plasma-Derived Biological Product, Animal Plasma or Serum-Derived Product. For these products, FDA is now implementing the BLA (revised Form FDA 356h) and will accept that application, instead of two separate license application submissions, the product license application (PLA) and the establishment license application (ELA).
Scope & Applicability
Product Classes
2The guidance applies to the CMC and Establishment Description sections for these products.
The guidance applies to the CMC and Establishment Description sections for these products.
Stakeholders
1parties responsible for manufacture or testing; Manufacturers responsible for portions of manufacture
Regulatory Context
Attributes
3measured during operations to prevent contamination; Floor diagram of facility areas should include air quality classification
used in routine monitoring programs
used in routine monitoring programs
Identified Hazards
Hazards
3Risk identified through donor screening and marker rates
Facilities designed to prevent cross-contamination
Causative agent requiring inactivation controls
See Also (8)
- On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test: Guidance for Industry (Status: Final)
- Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process (Status: Final)
- Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product: Guidance for Industry (Status: Final)
- Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product: Guidance for Industry (Status: Final)
- CVM GFI #187A Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach (Status: Final)