This edition of Quick Notes reviews four CHMP positive opinions, including a once-weekly insulin treatment for patients with type 2 diabetes, an oral monotherapy for patients with a rare blood…

Sol-Millennium, one of the three syringe manufacturers called out in a March 19 FDA Safety Communication for potential device failures, says it is “confident” that it can resolve all issues…

Those who work with laboratory developed tests (LDT) would have much preferred their rapidly developing field be regulated by the Verifying Accurate, Leading-edge IVCT Development (VALID) Act — but since…

In a nod to the increasing potential of demonstrating drug/biologic safety and/or effectiveness through noninterventional studies, the FDA has published long-awaited draft guidance on designing and analyzing such studies with…

This edition of Quick Notes reviews Becton Dickinson’s increase in U.S. manufacturing of syringes, clearance of the twiist Automated Insulin Delivery system, a new indication for Amplify standalone bone graft…

Medicare coverage of anti-obesity medications (AOM) — now CMS approved for cardiac patients — could drive up the federal deficit over the next decade, according to a new report issued…

The EU’s Environment, Public Health and Food Safety Committee (ENVI) has supported a legislative proposal that would grant up to 7.5 years of regulatory data privacy to pharmaceutical companies developing…

Three plastic syringe makers have received FDA warning letters describing violations related to the sale and distribution of plastic syringes made in China that have not been cleared or approved…

An FDA proposed rule will establish criteria the agency will use to create two lists — drug products and categories of drug products — that present demonstrable difficulties for compounding…

Devicemakers considering how to comply with the recently released Quality Management System Regulation (QMSR) will need to keep on hand a copy of the international standard ISO 13485 — the…