Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs in Prescription Drug User Fee Act

OMB 0910-0746

OMB 0910-0746

This information collection supports Food and Drug Administration (FDA) performance goals and procedures as set forth under the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA). These goals are the result of agency, industry, and public input, as Congressionally mandated under the applicable statutes and represent the renewed performance goals agreed to by FDA in support of these respective programs.

The latest form for Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs in Prescription Drug User Fee Act expires 2022-09-30 and can be found here.

OMB Details

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Federal Enterprise Architecture: Health - Consumer Health and Safety


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