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Generic Firms Want Looser Bioequivalence, But Change May Be Difficult For FDA

 
• By Michael Cipriano

Sponsors contend that changes to bioequivalence guidances in the middle of a review cycle have delayed approvals; FDA says rule changes might be difficult because of existing regulations.

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Generic sponsors are requesting that the US FDA review and approve abbreviated new drug applications (ANDAs) using existing standards even when a relevant bioequivalence guidance is changed in the middle of the review process so long as the change does not involve safety and efficacy of the product.

"Over the years, FDA continues to change the goalposts, and what may have been acceptable in the past with approved ANDAs is no longer the standard for many applications that were submitted years ago," Scott Tomsky, vice president of North America regulatory affairs at

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