The clock is ticking on the FDA’s enforcement discretion period for stem cells and other new therapies, and Congress raised concerns and questions with the agency about its plans going…
The FDA has approved new warnings for Xeljanz and Xeljanz XR (tofacitinib), including a boxed warning. The warning of an increased risk of blood clots and death applies to the…
The FDA hit Indoco Remedies with a warning letter for significant CGMP violations related to data integrity following an inspection of its production facility in Goa, India. Source: Drug Industry…
Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.)’s drug pricing package is headed to the Senate floor, following the Senate Finance Committee’s markup and 19-9 approval yesterday. Source: Drug Industry…
After months of criticism of the European Commission for the slow release of guidance on the EU’s new medical device regulations, the Commission released a flurry of documents on the…
Covington & Burling attorney Pamela Forrest offered insights into when devicemakers must file recall reports with the FDA to comply with 21 CFR Part 806 in a recent FDAnews webinar,…
The FDA cited four devicemakers following inspections that revealed problems with process controls, validations, complaint handling and medical devices reports. Source: The GMP Letter
A combination of real-world evidence and periodic reporting to the FDA should be the cornerstone of how the agency regulates AI and machine learning in software as a medical device,…
GS1 released updated guidance to help devicemakers comply with new unique device identifier requirements under the FDA’s updated standards. Source: The GMP Letter
The shortage of notified bodies to certify devices for the new EU medical device and IVD regulations appears to be reaching crisis point as more notified bodies say they won’t…