Recently Posted Guidance Documents

Recently Posted Guidance Documents

7/15/2020 - CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs 7/15/2020 - CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs 7/15/2020 - CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs 7/15/2020 - CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs 7/15/2020 - CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species  7/15/2020 - Clinical Investigations for Prostate Tissue Ablation Devices: Guidance for Industry and Food and Drug Administration Staff 7/15/2020 - Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff 7/14/2020 - Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Draft Guidance for Industry and Food and Drug Administration Staff 7/13/2020 - CPG Sec 540.750 - Use of The Seafood List to Determine Acceptable Seafood Names 7/13/2020 - Select Updates for Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff