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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
Adding a chapter to the prolonged, back-and-forth legal battle involving recalled continuous positive air pressure (CPAP) machines, Philips Respironics filed a complaint in a Pennsylvania federal court Friday insisting SoClean — manufacturer of ozone-based cleaning systems for breathing devices — pay part of a $1.1 billion settlement Philips reached last month with consumers who claimed they were injured by the devices. Read More
Cue Health must immediately stop sale and distribution of its COVID-19 tests and consumers should throw away any of the tests they may still have, the FDA says, following an inspection of the company’s San Diego facility last fall. Read More
Philips Respironics has recalled all Trilogy Evo ventilators that are not on the latest software update (1.05.06.00) due a software issue that can result in a sudden loss of ventilation while the device alarms. Read More