Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Proposed Rule

OMB 0910-0757

Latest Forms, Documents, and Supporting Material

Document Name
SUPPORTING STATEMENT 11-26-13.doc Supporting Statement A
Proposed Verification Requirements for NDA and BLA Holders Under 314.70(c)(8) and 601.12(f)(2)(iii)
Proposed Requirements for ANDA Holders under 314.70(c)(8) and 314.70(c)(8)(ii)