2016-23230: New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
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The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address.
The agency’s own summary, as published.
What this changes
Amends 6 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
- 21 CFR 510 New Animal Drugs
- 21 CFR 520 Oral Dosage Form New Animal Drugs
- 21 CFR 522 Implantation or Injectable Dosage Form New Animal Drugs
- 21 CFR 524 Ophthalmic and Topical Dosage Form New Animal Drugs
- 21 CFR 529 Certain Other Dosage Form New Animal Drugs
- 21 CFR 558 New Animal Drugs for Use in Animal Feeds
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