Two weeks past its deadline, the Environmental Protection Agency (EPA) announced its final amendments to the air toxics standards for ethylene oxide (EtO) commercial sterilization facilities, calling the additions “the…
The FDA’s legislative wish list for FY 2025 includes proposals to protect drug supply resiliency, amend the Hatch-Waxman Act, and exercise greater control over recalls. Source: Drug Industry Daily
Last month, signs that magrolimab increases the risk of death prompted Gilead to shelve the drug for blood cancer, Vertex’s second-gen cystic fibrosis combo leaves the company’s first-gen efforts in…
Par Pharmaceutical, a subsidiary of Endo International, announced a voluntary recall of one lot of treprostinil injection 20mg/20mL due to the potential for the presence of silicone particulates in the…
The FDA’s latest two draft guidances on medical devices address the ways in which submitters can request interactions with the agency and evaluating the thermal effects of devices that heat…
Human Microbes, a company promoting the value and sale of fecal microbiota transplants (FMT), has received an FDA Warning Letter listing a litany of regulatory violations, including lack of an…
The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) program is a great start for encouraging industry to develop these systems but it needs a lot more detail before…
The FDA has adopted an updated guidance from the International Council on Harmonisation (ICH) that provides clarification on how to factor in new and increasingly used data sources, such as…
This edition of Quick Notes reviews Wegovy’s new approval for cardiovascular event prevention, interchangeable approvals for biosimilars for Prolia and Xgeva, Biocon and Janssen’s settlement agreement for a Stelara biosimilar,…
Late Monday afternoon, the FDA announced its $7.2 billion budget request as part of President Biden’s $7.3 trillion fiscal 2025 proposed budget, which was released Monday. Source: Drug Industry Daily