Recently Posted Guidance Documents

Veterinary 5/23/2018 CVM GFI #132 Administrative Applications and the Phased Review Process 5/22/2018 CVM GFI #108 Registering with CVM’s Electronic Submission System 5/21/2018  CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs Drugs 5/23/2018 Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industr 5/22/2018 Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations 5/21/2018 Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment Compliance 5/22/2018 Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application Biopharmaceutics 5/21/2018  Bioanalytical Method Validation Guidance for Industry