Description
Section 512(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. §360b) establishes the requirements for a new animal drug approval. FDA regulations specify the information you (the sponsor) must submit as part of your new animal drug application (NADA) and the proper format for the NADA submission. 21 CFR 514.1. As part of your NADA submission, you must describe analytical procedures capable of determining the active component(s) of the new animal drug within a reasonable degree of accuracy and of assuring the identity of such components. 21 CFR 514.1(b)(5)(vii). This includes a description of practicable methods of analysis (assay methods) that have adequate sensitivity to determine the amount of the new animal drug in the final dosage form. 21 CFR 514.1(b)(5)(vii)(a). In the case of a Type A medicated article, the Type C medicated feed is a final dosage form used to treat the animal. Thus, as part of the NADA review process, FDA looks at assay methods for determining the amount of a new animal drug in Type C medicated feed.
Scope & Applicability
Product Classes
3Final feed administered to animals
The transfer study evaluates methods for drugs used in medicated animal feeds.
New animal drug dosage forms intended for use in the manufacture of medicated feeds; The primary product category discussed for CMC considerations.; manufactured for homogeneity, segregation, and stability studies
Stakeholders
10Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Individual communicating with the participating laboratory personnel.
Entity responsible for submitting applications under section 524B
Expert laboratory with experience performing the assay method.; The reference laboratory may also provide a separate report.; The sponsor's expert laboratory or contract lab with experience in the assay method.
Laboratory conducting the analytical phase of the transfer study.; Each participating laboratory should provide a report documenting their data.; The laboratory conducting the analytical phase of the transfer study.
Recommend that at least one of the laboratories be a state feed laboratory.
The individual responsible for overseeing the conduct and evaluation of the study.
individual responsible for evaluating potential risks
Personnel responsible for conducting the transfer study and evaluating results.
Person designated by ONADE to review the protocol and summary report.
Regulatory Context
Attributes
5Property of a device that may be changed via established protocols
Stability studies to justify assigned expiration or retest dates.
Long-term, accelerated, and intermediate conditions
Consistent with the known storage stability of the drug in the feed.
The concentration of the drug substance as determined by the reference laboratory.
Related CFR Sections (2)
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
- 21CFR558.4§ 558.4 Requirement of a medicated feed mill license.
(a) A feed manufacturing facility must possess a medicated feed mill license in order to manufacture a Type B or Type C medicated feed from a Category II, Type A medicated article.Read full regulation →
See Also (8)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
- CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission (Status: Final)
- CVM GFI #135 Validation of Analytical Procedures for Type C Medicated Feeds (Status: Final)
- CVM GFI #123 Development of Data Supporting Approval of NSAIDS for Use in Animals (Status: Final)
- CVM GFI #178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims (Status: Final)
- CVM GFI #5 Drug Stability Guidelines (Status: Final)
- CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products (Status: Final)
- CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals (Status: Final)