The FDA has quietly proposed legislation that would give it more authority to deem drugs misbranded in pharma DTC ads. But ...
Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027. This ...
This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to ...
Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile ...
Most drug and biological manufacturers met their postmarketing requirements (PMR) and postmarketing commitments (PMC) during ...
This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy for Low Risk Devices”[1] (the General Wellness Guidance), affects companies ...
President Donald Trump's administration is reclassifying state-licensed marijuana as a "less-dangerous" drug, Acting Attorney ...
Areas like generic drug regulation, drug supply chain and clinical trials reporting may be in need of some revamping by the Food and Drug Administration, according to a new Work Plan from the U.S.
FDA provided critical guidance for the advancement of CAD-1005 to pivotal Phase 3 in HIT Phase 2 data showed a greater than 25% absolute reduction in thrombotic events when CAD-1005 was added to ...
The US Food and Drug Administration (FDA) is authorized to regulate foods, dietary supplements, drugs, devices (including in vitro diagnostic), biologics, veterinary products, cosmetics and tobacco ...
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive ...
Morning Overview on MSN
FDA to pilot real-time tracking of clinical trials to speed safety feedback
When a patient in an early-phase drug trial experiences a serious side effect today, weeks or even months can pass before ...
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