Akan Biosciences, the manufacturer of a sterile injectable biologic product, received an FDA Warning Letter for failing to properly test donor tissue samples for communicable diseases and failing to have…
Congress needs to put more pressure on agencies like the FDA and the US Patent and Trademark Office (USPTO) to collaborate on fighting patent thickets, the multiple patents pharmaceutical companies…
Without strong economic incentives, the current antibiotic development pipeline won’t keep pace with burgeoning rates of antibiotic resistance, according to a new study by the International Federation of Pharmaceutical Manufacturers…
This edition of Quick Notes features announcements of Takeda, Abbvie and Novo Nordisk drug development collaborations and J&J’s acquisition of Proteologix. Source: Drug Industry Daily
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…