FDA Guidance Document Update: Recently posted guidance documents on veterinary medicine, drugs, emergency use, and medical product communications

Recently posted guidance documents on veterinary medicine, drugs, emergency use, and medical product communications

Animal & Veterinary

1/19/17: CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals

1/19/17: CVM GFI #236 Regulation of Mosquito-Related Products

Drugs

1/17/17: Assessment of Abuse Potential of Drugs

1/17/17: Considerations in Demonstrating Interchangeability With a Reference Product, Guidance for Industry

1/17/17: 2016 Medical Gas Container-Closure Rule Questions and Answers, Guidance for Industry

Emergency Use

1/13/17: Emergency Use Authorization of Medical Products and Related Authorities

Medical Product Communications

1/17/17: Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers, Guidance for Industry

1/18/17: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers, Guidance for Industry and Review Staff

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