Archive for August 2023

AdvaMed and the Medical Device Manufacturers Association (MDMA) commented this week on a CMS notice expediting Medicare coverage of emerging technologies, urging swift acceptance of the program, but also arguing that the proposal is limited in nature and doesn’t cover enough innovative devices. Source: Drug Industry Daily

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) want the FDA to close loopholes that keep generic drugs off the market, they said in a recent letter to FDA Commissioner Robert Califf. Source: Drug Industry Daily

FDA’s expedited regulatory programs cut up to two years off both clinical development and approval times for more than half of the drugs approved from 2015-2022, according to a new study. Source: Drug Industry Daily

The FDA has deemed Hamilton Medical’s recall of certain of its ventilators as class I, the most serious type of recall as use the device may lead to serious injury or death. Source: Drug Industry Daily

The FDA issued Outlook Therapeutics a complete response letter (CRL) on its BLA for Lytenava (bevacizumab), an investigational ophthalmic formulation under development to treat wet age-related macular degeneration (AMD). Source: Drug Industry Daily

After inquiries about food, the FDA Office of the Ombudsman hears most often from device companies — because there are more small companies in that area of the industry — and they need help to solve a problem they’re having with the agency, said office director Laurie Lenkel during an Alliance for a Stronger FDA…

Novo Nordisk has acquired Embark Biotech, as the larger Danish drugmaker looks to expand its blockbuster obesity drug portfolio in the wake of surging economic demand and rising market shortages of both metabolic and diabetes therapies. Source: Drug Industry Daily

Our coverage spans a bone graft product that caused a tuberculosis infection, a subcutaneous cancer treatment, a warning letter for an eye drop manufacturer, 300 higher risk patients with a recalled Medtronic cardiac pump, and a lawsuit by Insulet against a competitor for intellectual property theft. Source: Drug Industry Daily

The FDA issued three final guidances on Wednesday, one on the use of real-world data (RWD) in noninterventional (observational) studies and two on the Drug Supply Chain Security Act (DSCSA). Source: Drug Industry Daily

Upcoming events in the coming weeks include ten FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities and medical device counterfeiting. Source: Drug Industry…