FDA releases FY 2022 generic drug research summary

Regulatory NewsRegulatory News | 31 January 2023 |  By 

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Tuesday released a report summarizing its research activities in fiscal year 2022 in 13 different scientific areas under the Generic Drug User Fee Amendments (GDUFA III).
The research generated from the program enabled FDA to issue 177 new and revised product-specific guidances (PSGs), 59 of which were for complex products, according to the summary.
“The recommendations in many of these PSGs would not have been possible without the GDUFA science and research program,” wrote Susan Rosencrance, OGD’s acting director, and Michael Kopcha, director of FDA Office of Pharmaceutical Quality (OPQ).
Officials said that in fiscal year 2022, FDA published a PSG for a nusinersen sodium intrathecal solution to treat patients with spinal muscular atrophy, which was the first PSG for this class of oligonucleotide drugs. The guidance provided recommendations on assessing pharmaceutical equivalence for this product.
FDA officials also credit the research behind some approvals this year, including the approval of Allergan’s Restasis, the first generic cyclosporine ophthalmic emulsion, on 2 February 2022. The product “helps millions of patients in the United States who suffer from dry eyes.”  
The product “was exceptionally challenging to demonstrate [bioequivalence] and to assess product quality, for multiple reasons.”
The other noteworthy approval was Mylan’s Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol to treat asthma and chronic obstructive pulmonary disease (COPD) on 15 March 2022.
“This is one of the most commonly prescribed complex drug-device combination products to treat asthma and chronic obstructive pulmonary disease in millions of Americans, many of whom are children,” states the report.
The report also describes active research projects and outcomes organized in 13 scientific areas, which address complex ingredients, formulations or dosage forms; complex delivery routes; drug-device combination products; and tools and methods used to determine bioequivalence.
FDA awarded eight new research contracts and seven new grants in FY 2022 for extramural research projects relevant to generic drugs.
For example, on the research topic of complex mixtures and peptide products, FDA awarded a contract to the University of Maryland at Baltimore to study a multidimensional analytical and computational approach to determine diastereomer compositions in oligonucleotide drugs.
The research priorities for FY 2022 were announced by FDA last December 2021 (RELATED: FDA announces FY 2022 GDUFA science and research priorities. Regulatory Focus, 2 December 2021).


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Tags: FDA, GDUFA, III, OGD, research

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