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Four units within the FDA have worked together to publish a paper to provide greater transparency on how they will collaborate with the pharmaceutical industry as it develops and deploys AI technologies. Read More
The FDA has issued a final guidance on the process generic drug manufacturers can use to correspond with the agency on generic drug development, the agency’s process for responding and for manufacturers to clarify ambiguities in what the FDA refers to as “controlled correspondence.” Read More
In a 12 to 2 vote Thursday, an FDA advisory committee gave a thumbs up to Geron Corporation’s imetelstat for treating transfusion-dependent (TD) anemia in adults with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS), who are ineligible or don’t respond to erythropoiesis-stimulating agents (ESAs). Read More
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. Read More
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 product solution. Read More
The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) program is a great start for encouraging industry to develop these systems but it needs a lot more detail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 businesses will wholeheartedly embrace it, according to stakeholder comments. Read More
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 social media or patient support programs, when reporting individual case safety reports postapproval. Read More
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. Read More