Notifications of suspensions

General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0338 can be found here:

Documents and Forms

Document Name Document Type
Form 356h Notifications of suspensions Form and Instruction
356h Application to Market a New Drug or Biologic for Human Use FORM FDA 356h revised 2-28-14.pdf Form and Instruction

Information Collection (IC) Details