356h Application to Market a New Drug Biologic or an Antibiot
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567
FORM FDA 356h 11-5-13.zip
601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies
OMB: 0910-0338
⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0338 can be found here: