Drugs

GDUFA 2022 Science and Research Report

FDA’s 2022 GDUFA Science and Research Report says that during FY 2022 FDA awarded eight new research contracts and seven new grants (not including supplements to existing projects) for innovative extramural research projects relevant to generic drugs. The report says the agency also used its laboratories and computer systems to conduct more than 70 intramural GDUFA science and research projects that leveraged FDA resources and expertise to facilitate both generic product development and FDA’s preparedness to assess information submitted to ANDAs.

“The outcomes from GDUFA-funded research expand our understanding of drug products, including complex products, and often contribute to the development of advanced methods to characterize product quality and performance,” FDA says. “These methods may play a critical role in determining how FDA evaluates the quality and bioequivalence of complex generic products and can establish the scientific basis for novel and more efficient pathways by which to develop generic products.”

In FY 2022, the report says, FDA issued 177 new and revised product-specific guidances (PSGs), 59 of which were for complex products. The guidances gave recommendations for developing generic drugs and generating the evidence to support ANDA approval. The report says the recommendations in many of the PSGs would not have been possible without the GDUFA science and research program.

The report describes active research projects and outcomes organized in 13 scientific areas: ophthalmic products; complex mixtures and peptide products; long-acting injectable, insertable, or implantable products; complex injectables, formulations and nanomaterials; inhalation and nasal products; topical products; locally-acting physiologically based pharmacokinetic modeling; quantitative clinical pharmacology; oral absorption models and bioequivalence; patient substitution of generic drugs; abuse-deterrent opioid drug products; data analytics; and drug/device combination products.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome