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Guidance Issuing OfficeCenter for Veterinary Medicine
This guidance provides recommendations to holders of new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) who intend to make post-approval chemistry, manufacturing, and controls (CMC) changes in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR 514.8. The guidance covers recommended reporting categories for post-approval changes for animal drugs. Recommendations are provided for post-approval changes in: (1) components and composition, (2) manufacturing sites, (3) manufacturing process, (4) specifications, (5) container closure system, as well as (6) miscellaneous changes and (7) multiple related changes.
This guidance does not provide recommendations on the specific information that should be developed by an applicant to assess the effect of the change on the identity, strength (e.g., assay, content uniformity), quality (e.g., physical, chemical, and biological properties), purity (e.g., impurities and degradation products), or potency (e.g., biological activity, bioavailability, bioequivalence) of a drug as these factors may relate to the safety or effectiveness of the drug. An applicant should consider all relevant FDA guidance documents for recommendations on the information that should be submitted to support a given change.
FDA has published guidances, including the SUPAC (scale-up and postapproval changes) guidances, that provide recommendations on reporting categories. To the extent that the recommendations on reporting categories in this guidance are found to be inconsistent with guidances published before this guidance was finalized, the recommended reporting categories in such previously published guidances are superseded by this guidance. This guidance does not provide extensive recommendations on reporting categories for components and composition changes (see section V). Therefore, recommended reporting categories for components and composition changes provided in previously published guidances, such as the SUPAC guidances, still apply. Section 506A of the Act and 21 CFR 514.8(b)(3) provide for two types of changes-being-effected supplements (see section II), while previously there was only one type. It is important for applicants to use this guidance to determine which type of changes-being-effected supplement is recommended. FDA intends to update the previously published guidances to make them consistent with this guidance.
If guidance for either recommended filing categories or information that should be submitted to support a particular change is not available, CVM’s Division of Manufacturing Technologies, HFV-140, should be consulted.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1999-D-0011.