A Hyman, Phelps & McNamara medical device regulatory expert and attorney say FDA should help industry learn how to avoid labs that produce fraudulent ...
FDA warns Gainesville, FL-based Exactech about Quality System and Medical Device Report violations in its manufacturing of orthopedic implants and acc...
FDA publishes a draft guidance with recommendations for NDA and ANDA applicants for nonprescription drugs to document minor labeling changes.
CVM warns Boehringer Ingelheim Animal Health USA that promotional communications for its Senvelgo make false and misleading claims that contradict the...
FDA publishes a draft guidance proposing select updates to its existing premarket cybersecurity guidance.
A Duke-Margolis Institute for Health Policy report on an FDA-funded virtual workshop on drug digital marketing identifies several cross-cutting themes...
FDA and Instem researchers say 92% of Medical Device Reports filed between 2011 and 2021 involved device issues rather than patient adverse events.
Pfizer plans to share with FDA favorable data from its Phase 3 study of the antibody-drug conjugate Adcetris (brentuximab vedotin) in combination with...
