Unlock regulatory insights with Watson. Learn More
Return to Docket

Draft Guidance for Industry and FDA Staff; Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA; Availability

Type: Non-Rule Making
KeyWord(s) oc, oc2011412 , draft guidance , postapproval , BLA, NDA, PMA, device premarket approval application
Docket Item Code D
Center OC

5 Comments