USA – FDA announces FY 2022 GDUFA science and research priorities

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has announced its science and research priorities for fiscal year (FY) 2022 to spur the development of complex generic drugs. The priorities were prompted by public feedback the agency received at a public workshop earlier this year.

The agency also announced the availability of fellowships and funding for research activities that are aligned with these priorities.

The workshop was held in June 2021 on accelerating complex generic development. The feedback resulted in FDA’s revising several priority areas, said FDA in a four-page summary of its Generic Drug User Fee Amendments (GDUFA) science and research priority initiatives for FY 2022. (RELATED: FDA’s OGD hears ways to accelerate complex generic development, Regulatory Focus 24 June 2021)

Such feedback included prioritizing the global harmonization of bioequivalence (BE) standards. At the June workshop, Raja Velagapudi of Sandoz had put forward a proposal that FDA work with the International Council for Harmonization (ICH) on mutual use of bioequivalence data to ease the testing burden for approval of some generics…