Guidance for Industry - Regulatory Issues

Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA
DRAFT GUIDANCE
This draft guidance document is being distributed for comment purposes only.
This guidance document represents the agency's current thinking on this matter. It does not create or confer any rights for or on any person and does not operate to bind the FDA or public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations or both.
Comments and suggestions regarding this draft document should be submitted within 75 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions on the content of the draft document contact Dennis Bensley, 301-827-6956 (Center for Veterinary Medicine).
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine (CVM)
June 1999
I. INTRODUCTION
On November 21, 1997, the President signed the Food and Drug Administration Modernization Act (the Modernization Act).2 Section 116 of the Modernization Act amended the Food, Drug, and Cosmetic Act (the Act) by adding section 506A (21 U.S.C. 356a), which provides requirements for making and reporting manufacturing changes to an approved application and for distributing a drug product made with such change. The Food and Drug Administration (FDA) is proposing to amend its regulations on supplements and other changes to an approved application for new animal drugs (21 CFR 514.8) to conform to section 506A of the Act.
The purpose of this draft guidance is to provide recommendations to holders of new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) who intend to make postapproval changes in accordance with Section 506A and the proposed amended regulations at 21 CFR 514.8. The guidance covers recommended reporting categories for postapproval changes for new animal drugs. Recommendations are provided for postapproval changes in: (1) components and composition, (2) sites, (3) manufacturing process, (4) specification(s), (5) package, and (6) miscellaneous changes. This draft guidance document, which cites proposed 21 CFR 514.8, will be revised based on public comments and implemented for use as a companion document when 21 CFR 514.8 is finalized.
This guidance does not provide recommendations on the specific information that should be developed by an applicant to validate 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 product as they may relate to the safety or effectiveness of the product. FDA has published guidances, including the SUPAC (Scale-up and Postapproval Changes) guidances, that provide recommendations on reporting categories and/or the type of information that should be developed by the applicant to validate the effect of the change on the identity, strength, quality, purity, or potency of a product as they may relate to the safety or effectiveness of the product. To the extent that the recommendations on reporting categories in this guidance, when finalized, are found to be inconsistent with prior published guidance, such as the SUPACs, the recommended reporting categories in such prior guidance will be superseded by this guidance. FDA intends to update the prior published guidances to make them consistent with this guidance. An applicant should consider all relevant CDER and CVM guidance documents for recommendations on the information that should be submitted to support a given change. If guidance for either recommended filing categories and/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.
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