Drugs

Generic Drug Research Focuses on Complex Drugs: Report

CDER has released its FY 2021 GDUFA Science and Research Report that updates stakeholders on the development of innovative methodologies and more efficient tools to help establish drug equivalence standards to support generic drug development. Much of the research is focused on complex products, which often have few generics or none at all, according to the agency.

For example, the report notes that for complex generics in FY 2021, FDA awarded six new research contracts and 10 new grants (not including supplements to existing projects) for innovative extramural research projects. “FDA also utilized its laboratories and computer systems to conduct more than 80 intramural GDUFA Science and Research projects focused on how to best use our resources to improve generic drug development and regulatory assessment,” the report says.

FDA’s research efforts also help expand the agency’s understanding of complex products and “often contribute to the development of advanced methods to characterize product quality and performance,” the report says. “These methods may play a critical role in determining how FDA evaluates the quality and bioequivalence of complex generic products and establish the scientific basis for novel and more efficient pathways by which to develop complex generics.”

Regarding new bioequivalence and quality recommendations communicated to the generic drug industry, FDA in FY 2021 issued 135 new and revised product-specific guidances (53 were for complex products). “In addition to informing FDA guidances, GDUFA research outcomes also allow FDA to clarify whether proposed bioequivalence approaches presented to FDA in pre-ANDA product development meetings are likely to be suitable and provide prospective ANDA applicants with scientific and technical advice that helps them prepare their submissions in a manner compatible with the most current scientific insights and regulatory expectations,” the report says. Additionally, FDA last year held 87 product development and pre-submission pre-ANDA meetings.

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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