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  1. Guidance for Industry

Newly Added Guidances

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
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
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
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing 6/19/2020
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry 6/16/2020
Guidance for Industry: Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency 6/4/2020
CVM GFI #240 Proprietary Names for New Animal Drugs 6/1/2020
Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic 5/12/2020
CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency 5/7/2020
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency 4/22/2020

 

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