The FDA has a lot of work to do to regain trust among a wide swath of demographic groups — starting with women — according to a recent survey. Source:…

In an analysis that seeks to help frame the discussion at the upcoming Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, the FDA says that a law enacted in…

Joining three other Eugia Pharma plants in India, the company’s facility in Bhiwadi, Rajasthan, was handed a Form 483 from the FDA, citing observations of operators not following procedures in…

Wayne Pines, senior director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, reviews the landscape for the “clear, conspicuous and neutral” manner…

The FDA has imposed import alerts on two additional Chinese manufacturers of plastic syringes, preventing these products from entering the US, and is warning healthcare practitioners as well as consumers…

As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…

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,…