Drugs

FY 2020 GDUFA Science and Research Highlights

In FY 2020, FDA awarded 11 new research contracts and five new grants (not including supplements to existing projects) for innovative extramural research projects relevant to generic drugs. The FY 2020 GDUFA Science and Research Report from the CDER Office of Generic Drugs and Office of Pharmaceutical Quality says FDA also used its laboratories and computer systems to conduct more than 50 projects focused on best using resources to improve generic drug development and regulatory assessment.

“Our GDUFA-funded research collaborations have resulted in significant accomplishments related to developing the scientific basis that supports new and revised product-specific guidances and general guidances for industry, and in refining methods for the scientific evaluation of quality and equivalence for generic drug products,” the report says.

It gives detailed results for 13 areas of focus, including a summary of research activities, research highlights, comprehensive lists of grants and contracts, and outcomes that the GDUFA Science and Research program funded in 2020.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome