Guidance Documents will be retained in this section of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.
Title |
Issue Date |
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Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide |
October 29, 2021 |
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act |
October 29, 2021 |
CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs |
October 6, 2021 |
CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs |
October 6, 2021 |
CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs |
October 6, 2021 |
CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs |
October 6, 2021 |
CVM GFI #253 Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products |
September 23, 2021 |
CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products |
September 23, 2021 |