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. Source: Drug…
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…
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…
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,…
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…
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’…
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…
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,…
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…
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…