We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A recall of more than 1 million Boston Scientific angiographic catheters from certain batches has been considered Class I by the FDA due to an increase in complaints about an inability to advance the guidewire through the lumen of the device for certain batches. Read More
A patient-reported outcome instrument that assesses vision symptoms before and after intraocular lens implant surgery is now a part of the Medical Device Development Tools (MDDT) program.
The FDA has published 32 new and revised draft product-specific guidances (PSG) which provide recommendations for developing generic drugs and the design of bioequivalence studies to support ANDAs. Read More
Eli Lilly entered into a settlement agreement with Totality Medispa for monetary payment and to halt further sale of unapproved versions of the company’s monumental Type 2 diabetes and weight loss drugs, Mounjaro and Zepbound (tirzepatide). Read More
For the third time this year, the FDA has deemed an Abbott recall of its HeartMate 3 Left Ventricular Assist System (LVAS) as Class I, the most serious type of recall, following 81 reported incidents, 70 injuries and two deaths related to the issue. Read More
More than 1,400 patents and patent applications — most filed years after drug approval — protect the US’ 10 top-selling drugs, heading off competition from generics or biosimilars for decades, a new study has found. Read More
Dynavax announced it received an FDA complete response letter (CRL) on its sBLA for Heplisav-B vaccine because the third-party clinical trial site operator destroyed the data for approximately half the subjects. Read More
Sen. Bernie Sanders (I-Vt.) has raised his battle flag against high drug prices on a crumbling hill, according to a conservative think tank that’s picking apart a study supporting Sanders’ views on the matter. Read More
If CDRH doesn't get $11.5 million from Congress this year to keep up its program to prevent medical device supply chain disruptions, the program will go dark next year, said center director Jeff Shuren on Tuesday during an Alliance for a Stronger FDA webinar focused on the budget. Read More
The 2023 annual survey of members of Team NB, The European Association Medical Devices — Notified Bodies, shows a steady increase in both applications and certificates issued by association members, as well as an increase in number of notified bodies. Read More
Sandoz is withdrawing from the UK’s Prescription Medicines Code of Practice Authority (PMCPA) after being dinged for promotional wording of its biosimilar natalizumab in official documents presented before the drug received a national marketing authorization. Read More