Immunogenicity References

This draft guidance (GFI #256B) describes circumstances where FDA generally does not intend to take enforcement action against the compounding of animal drug products from bulk drug substances at facilities registered under sections 503B(b) or 510(b) of the FD&C Act operating under current good manufacturing practice (CGMP). It extends FDA's...

This final guidance explains the criteria FDA uses to evaluate the therapeutic equivalence (TE) of drug products and what TE codes indicate for multisource prescription drug products listed in the Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). This guidance finalizes the draft guidance of the same title...

This draft guidance provides recommendations for developing assays to evaluate potency as part of a potency assurance strategy for active immunotherapy products (ACTIMPs), including peptide- and protein-based ACTIMPs that are not cellular or gene therapy products. It supplements FDA's December 2023 draft guidance "Potency Assurance for Cellular and Gene Therapy...

This final guidance provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products, spanning regulatory review, chemistry, manufacturing, and controls (CMC), pharmacology/toxicology, clinical, and clinical pharmacology topics. This guidance finalizes the draft version issued in...

This draft guidance describes FDA's current thinking on determining whether to submit an Abbreviated New Drug Application (ANDA) under section 505(j) of the FD&C Act or a 505(b)(2) application, including criteria for choosing between the two pathways and how to seek FDA's assistance. This revised draft updates and supersedes the...

This guidance describes FDA's current thinking on the use of Type VII Veterinary Master Files (Type VII VMFs), which are appropriate for the research and development of animal cells, tissues, and cell- and tissue-based products, gene therapies, and heritable intentional genomic alterations in animals....

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This draft guidance provides a risk-based framework for evaluating the quality of container closure systems (CCSs) used with human drugs and biological products, including quality assessments and quality control of packaging materials and components. It applies to new applications, amendments, supplements, and legally marketed drugs under section 505G, and FDA...

This guidance provides recommendations to sponsors and applicants of Prescription Drug User Fee Act (PDUFA) products on formal meetings with FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, including principles of good meeting management, procedures for requesting and conducting meetings, meeting types and formats,...

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