Description
For new animal drug applications, FDA requires full reports of investigations which have been conducted to show a drug is safe and effective for use [section 512(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)]. Additionally, section 512(n)(1)(E) of the FD&C Act requires that abbreviated applications for the approval of a new animal drug contain information to show that the new animal drug is bioequivalent to the approved new animal drug.
Scope & Applicability
Stakeholders
2Person whose actions may cause a product to be deemed adulterated
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
3randomization, for example, any stratification variables (e.g., weight, sex).
Standard component of electronic systems to ensure trustworthiness.
Requirement for abbreviated applications for new animal drugs
Related CFR Sections (1)
- 21CFR58.3§ 58.3 Definitions.
As used in this part, the following terms shall have the meanings specified:Read full regulation →
See Also (8)
- CVM GFI #13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated Block
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species
- CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications
- CVM GFI #224 (VICH GL52) Bioequivalence: Blood Level Bioequivalence Study
- 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
- CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices
- FDA's Strategy on Antimicrobial Resistance - Questions and Answers
- CVM GFI #5 Drug Stability Guidelines