Description
In the Federal Register of May 14, 1996, the Food and Drug Administration published the final rule ?Elimination of the Establishment License Application for Specified Biotechnology and Specified Synthetic Biological Products”. Under this rule manufacturers of therapeutic recombinant DNA-derived products and/or monoclonal antibody products for in vivo use are no longer required to submit an Establishment License Application and may use the interim FDA Form 3439.
Scope & Applicability
Product Classes
2License applications for therapeutic products
The primary subject of the sameness interpretation
Stakeholders
5required for animals used in production
Assess the suitability and competence of potential contractors before outsourcing operations
organisms meeting GLSP criteria do not require inactivation
Entity responsible for submitting NDINs
Contract acceptor for transportation of APIs
Regulatory Context
Attributes
5Term used for materials instead of potency.
An increase in this attribute generally does not require a new 510(k) if protocols are met.
operating and control parameter for cell growth
used for characterization of MCB for identity and purity
Measured during operations in manufacturing areas
Identified Hazards
Hazards
4microbiological contamination risk in bulk solution
Adventitious Agents Safety Evaluation for sterile products
Output attribute considered an EC in minimal approach
Facilities designed to prevent cross-contamination
Related CFR Sections (1)
- 21CFR10.90§ 10.90 Food and Drug Administration regulations, recommendations, and agreements.
(a) Regulations. FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both.Read full regulation →
See Also (8)
- Topical Dermatologic Corticosteroids: in Vivo Bioequivalence (Status: Final)
- Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (Status: Final)
- CVM GFI #57 Preparation and Submission of Veterinary Master Files (Status: Final)
- SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (Status: Final)
- 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)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)