Description
This guidance discusses immunogenicity-related considerations for low molecular weight heparin (LMWH) products and finalizes the draft guidance titled Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs that was published on April 9, 2014 (79 FR 19621). Section II includes background information. Section IIIA includes recommendations on meeting the requirement for active ingredient sameness for abbreviated new drug applications (ANDAs) for LMWHs, which helps to address immunogenicity-related considerations in the context of ANDAs.
Scope & Applicability
Product Classes
1LMWH products are anticoagulants used for the prevention and treatment of thrombosis; LMWH products subject to immunogenicity considerations; Assessment of immune activation elicited by the LMWH
Stakeholders
1Drug Master File holders included in the term 'manufacturers and applicants'.
Regulatory Context
Attributes
4Provide data on close-to-expiry product lots
changes to source material or components requiring a PAS
Key feature for demonstrating equivalence
Provide data on mid-expiry-cycle product lots
Identified Hazards
Hazards
1Safety concern if product heterogeneity is inconsistent
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 →
- 21CFR314.97§ 314.97 Supplements and other changes to an approved ANDA.
(a) General requirements. The applicant must comply with the requirements of §§ 314.70 and 314.71 regarding the submission of supplemental ANDAs and other changes to an approved ANDA.Read full regulation →
- 21CFR314.420§ 314.420 Drug master files.
(a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigationalRead full regulation →
See Also (8)
- Postapproval Changes to Drug Substances Guidance for Industry (Status: Draft)
- SUPAC-IR Questions and Answers about SUPAC-IR Guidance (Status: Final)
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
- Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (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)