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

601.27(b) - Pediatric Studies - Deferred Submission

OMB: 0910-0338