The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to ...
June 22 (Reuters) - The U.S. Food and Drug Administration said on Monday it is launching a series of measures to speed up drug research, from early-stage investigational studies to late-stage trials, ...
The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions ...
On June 22, 2026, the U.S. Department of Health and Human Services (HHS) announced the launch of Operation TrialBlazer, a coordinated effort ...
FDA’s recently unveiled 2025 Human Foods Program guidance agenda offers a detailed view of the agency’s priorities for the year ahead. The document is non-binding, but provides critical insight into ...
The U.S. Food and Drug Administration (FDA) has officially dropped its warning letter and enforcement complaint against Whoop ...
The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump ...
Whoop made changes to its blood pressure insights feature that satisfied the FDA’s requirements for wellness devices.
FDA plans to limit the regulation of wearable medical devices, according to a January 6 notice from the agency. Currently, the majority of fitness tracking wearables and fitness apps are classified as ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Sworn Declarations from Former FDA Counsel and Renowned Device Regulation Expert Expose Clear Regulatory Carve-Outs for Outpatient Clinics; Emergency Motion Seeks to Strike Verdict Before July 7 Sente ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results