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Regulatory Focus™ > News Articles > 2020 > 4 > FDA guides generic drugmakers on bioequivalence study disruptions amid COVID-19

FDA guides generic drugmakers on bioequivalence study disruptions amid COVID-19

Posted 29 April 2020 | By Michael Mezher 

FDA guides generic drugmakers on bioequivalence study disruptions amid COVID-19

The US Food and Drug Administration (FDA) on Tuesday gave advice to generic drugmakers on handling disruptions to bioequivalence studies needed to support abbreviated new drug application (ANDA) approval as a result of the coronavirus disease (COVID-19) pandemic.
On top of the massive health and economic toll caused by the outbreak, clinical trials have been particularly hard hit as dozens of drugmakers have halted or delayed studies and as they grapple with the impact of the virus and social distancing measures. Similarly, multiple clinical research organizations have said a large number of their trial sites have been impacted by the pandemic.
For bioequivalence studies, FDA says that “Challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the proposed generic product or the reference listed drug product, or other considerations if site personnel or study subjects become infected with COVID-19.”
FDA also points out that interruptions to bioequivalence studies could require protocol changes and disrupt the collection of information from studies.
FDA says that companies conducting in vivo bioequivalence studies should “prioritize the protection of the study participants,” and directs them to its guidance on managing clinical trials during the pandemic. (RELATED: FDA Unveils Guidance for Trials Impacted by COVID-19, Regulatory Focus 18 March 2020; Clinical trials during COVID-19: Updates from FDA, MHRA and TGA, Regulatory Focus 1 April 2020; FDA, EU authorities update guidance on clinical trials during COVID-19, Regulatory Focus 28 April 2020).
Companies planning to submit ANDAs whose bioequivalence studies are impacted by the virus are instructed to use the controlled correspondence process with any questions related to protocol revisions and information collection. (RELATED: FDA Drafts Guidance on Controlled Correspondence Under GDUFA II, Regulatory Focus, 2 November 2017).
FDA also says that companies can contact the Office of Generic Drugs to notify it of interrupted bioequivalence studies. Doing so, FDA says, will “help FDA identify the needs for additional information or guidance on these matters.”
Robert Pollock, senior advisor at Lachman Consultants, told Focus that on top of the issues FDA is anticipating, “There will probably be a lot of questions the agency has not even contemplated.” Pollock also said it will be important for companies to get advice on protocols for bioequivalence studies that are starting soon or just getting underway.

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