Description
Section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360b) establishes the requirements for new animal drug approval. FDA regulations specify the information you must submit as part of your new animal drug application (NADA) and the proper format for the NADA submission. 21 CFR part 514. As part of your NADA submission, you must include a “detailed description of the collection of samples and the analytical procedures to which they are subjected.” 21 CFR 514.1(b)(5)(vii). This should include a description of practicable methods of analysis 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).
Scope & Applicability
Product Classes
3Complete feeds that can be fed as is.
The primary product category covered by this guidance; Subject of the bioequivalence guidance for poorly soluble APIs.
Supplements or intermediates that must be diluted.
Stakeholders
2Entity responsible for submitting applications under section 524B
determines frequency and acceptance criteria of system suitability evaluations; person who modifies instrument conditions during robustness testing
Regulatory Context
Attributes
6The time a drug takes to pass through the column, used for identification.
Performance characteristic to be validated
The calculated amount of drug in the feed, defined by specific units and equations.
Determined by the sponsor for the investigational product.; investigational product(s) are stable over the period of use and only used within the current shelf life
Measurement of potency for biological products
A chromatographic performance criterion used to evaluate the acceptability of results.
Identified Hazards
Hazards
1specific procedures for the safe handling of hazardous chemicals and reagents
Related CFR Sections (1)
- 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 →
See Also (8)
- CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission (Status: Final)
- CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals (Status: Final)
- CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (Status: Final)
- CVM GFI #218 Cell-Based Products for Animal Use (Status: Final)
- CVM GFI #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle (Status: Final)
- CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution Reporting (Status: Final)
- CVM GFI #3 General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals (Status: Final)
- CVM GFI #108 Registering with CVM’s Electronic Submission System (Status: Final)