Interviews

Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs

Documents and Forms

Document Name Document Type
PDUFA VII - Commitment Letter 2023 through 2027.pdf www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027 Other-Agency Performance Goals
BsUFA III Commitment Letter 2023 through 2027.pdf www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027 Other-Agency Performance Goals

Information Collection (IC) Details