Description
This guidance provides recommendations to sponsors on submission of raw data. In addition, this guidance discusses how CVM uses the raw data during review of new animal drug applications and how the raw data allows CVM to have confidence in the information used to make regulatory decisions.
Scope & Applicability
Product Classes
1New Animal Drug
The category of products covered by this guidance.
Stakeholders
1Animal Drug Sponsor
Entity subject to user fees under the FD&C Act
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