Description
FDA is issuing this guidance document as part of its on-going initiatives to provide manufacturers with increased flexibility to bring important and improved human biological products to market more efficiently and expeditiously. This document addresses the concept of product comparability and describes current FDA practice concerning product comparability of human biological products regulated by the Center for Biologics Evaluation and Research (CBER), including therapeutic biotechnology-derived products, regulated by CBER, and therapeutic biotechnology-derived products regulated by the Center for Drug Evaluation and Research (CDER). It describes those steps that manufacturers may perform and which FDA may evaluate to allow manufacturers to make manufacturing changes without performing additional clinical studies to demonstrate safety and efficacy.
Scope & Applicability
Product Classes
2Specific category of biological products
Subject of comparability guidance
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
2specifications for the purity, strength, and composition of dietary supplements
Measurement of potency for biological products
Related CFR Sections (3)
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.
(a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →
See Also (8)
- Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Status: Final)
- Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry (Status: Draft)
- Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry (Status: Final)
- Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry (Status: Final)
- Use of Sterile Connecting Devices in Blood Bank Practices: Guidance for Industry (Status: Final)
- Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax: Guidance for Industry (Status: Final)