Bioavailability Bioequivalency Production Regulation 
FDA Law Blog
JULY 6, 2021
Circuit, their client Nostrum Laboratories sought judicial review after FDA agreed to allow a certain type of study to establish bioequivalence for generic theophylline, Nostrum conducted those studies, and then FDA issued a CRL asking for new, time-consuming, expensive studies of a different sort.
FDA Law Blog
JULY 9, 2024
Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. For drugs, the relevant studies are any Phase 3 study or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies). 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). . §
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