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Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Proposed Rule
OMB 0910-0757
OMB.report
HHS/FDA
OMB 0910-0757
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)
All Historical Document Collections
201312-0910-001
Comment filed on proposed rule
New collection (Request for a new OMB Control Number)
2013-12-06
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