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Teva Pharmaceuticals USA Inc.

Latest From Teva Pharmaceuticals USA Inc.

FDA Change In Bioequivalence Requirements Leads To Downgrade Of Accord’s Generic Tacrolimus

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.

Generic Drugs Post Market Regulation & Studies

Artificial Intelligence: Industry Wants FDA To Boost Access To Databases, Clarify Use In Assessing Drug Efficacy

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

Artificial Intelligence FDA

Informed Consent Final Guidance: Drug Makers Get Some Tweaks But Not Every Change They Wanted

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.

Guidance Documents Clinical Trials

Generic Hetlioz Does Not Require Braille Labeling, FDA Tells Vanda

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.

Generic Drugs Legal Issues
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