The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals to develop two agentic AI assistants for ...
13don MSN
Takeaways from the AP's report on turmoil surrounding the FDA's new fast-track drug program
A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and ...
13don MSN
Legal questions swirl around FDA's new expedited drug program, including who should sign off
The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...
After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...
The FDA has approved Augmentin XR, an oral antibacterial, under its Commissioner’s National Priority Voucher pilot program, marking the first approval granted through the expedited review pathway. The ...
The FDA is considering changes that could reshape how vaccines move from labs to American pharmacies — the most significant proposed shift in vaccine oversight since the early 2000s. While the agency ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
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