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Generic Drug Bioequivalence Study Interruptions Not Just A Coronavirus Problem

 
• By Derrick Gingery

US FDA should create a policy to help save troubled studies, because failure can kill generic development programs, Lachman Consultants’ Michelle Ryder suggests.

PCR strip test tubes and micropipette in genetics laboratory. Toned photo
Generic drug sponsors are looking for help from the FDA to "save" bioequivalence studies interrupted by coronavirus or other problems. • Source: Shutterstock

Generic drug sponsors want US Food and Drug Administration help to salvage bioequivalence studies disrupted by the coronavirus pandemic, but a consultant warned the problem will not disappear after the outbreak is contained.

Michelle Ryder, principal consultant in the regulatory practice at Lachman Consultants, said the help is vital for the industry, because re-running a whole BE study “can be a program killer.”

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