Application of User Fees New Guidance

Application of User Fees New Guidance

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Updates to the FDA’s guidance on application of user fees for combination products The FDA just updated its guidance on Application of User Fees...
FDA URRA New Draft Guidance

FDA URRA New Draft Guidance

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed The FDA has been extra busy this summer! Another key draft guidance has been published – this newest one on Use-Related Risk Analysis (URRA) for...