📋FDA Releases Guidance on Raw Data Submission for Animal Drugs
Raw Data for Safety and Effectiveness Studies; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #287 entitled "Raw Data for Safety and Effectiveness Studies." This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine's (CVM) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes our recommendations for submitting raw data.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document outlines final guidance on submitting raw data for safety and effectiveness studies related to new animal drug applications. This impacts businesses involved in animal health, as compliance with these regulations will be necessary for approvals.