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An FDA advisory committee on Thursday gave its unanimous blessing to Balance Opthalmics’ FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) system as a nightly use adjunct therapy for reducing intraocular pressure in adults with open-angle glaucoma and intraocular pressure 21 mmHg or less. Read More
The FDA has identified product recalls for Vyaire’s AirLife Manual Resuscitators and for the use instructions for Abiomed’s left-sided heart pumps as Class I, while device manufacturer InfuTronix is voluntarily recalling its line of Nimbus Infusion Pumps after design flaws prompted thousands of customer complaints. Read More
Over the past week, the FDA published a draft rule on drug products that present demonstrable difficulties for compounding. Final guidance was issued on controlled correspondence for generic drug development. Draft guidance on real-world evidence in drug and biological products’ non-interventional studies was also issued. Read More
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 disease, a new antibiotic to treat multi-drug resistant bacteria, and a generic multiple sclerosis drug treatment. Read More
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 identified in an FDA Warning Letter. Read More
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 Congress has repeatedly failed to pass the bipartisan act, the field is now reeling at the “overreach” of the FDA’s new proposed rule on regulating LDTs. Read More
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drug/biologic safety and/or effectiveness through noninterventional studies, the FDA has published long-awaited draft guidance on designing and analyzing such studies with real-world data (RWD) in mind. Read More
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 putty, and Fujifilm’s AI-powered endoscopic imaging technology. Read More
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 by the Congressional Budget Office (CBO). Read More
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 new drugs, effectively trimming six months of protection from the current eight years for some products. Read More
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 for sale or distribution in the U.S. Read More
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 (DDC Lists) and identify three categories of drug products on both DDC Lists. Read More