After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.

BIO, PhRMA, Genentech, Regeneron, AAM discuss transparency in use of AI, intellectual property protection, what constitutes AI, and its application in postmarketing safety surveillance.

From when the consent process starts to how to handle standard of care discussions, US FDA’s long-awaited final guidance on informed consent reflects some changes sought by sponsors. More changes may be in store soon due to revisions of the Common Rule.

FDA says Teva and Apotex’s generic products do not violate the ‘same labeling’ requirement because they were produced by different manufacturers and that braille is not necessary for safe and effective use of tasimelteon products. Vanda's generic labeling suit against the FDA remains pending.