STAT

A ‘historic’ FDA clearance raises the question: Is the LLM an interface or the decision-maker?

The newly cleared device is based around an app that helps a patient manage their diabetes using a treatment plan defined by ...

US FDA updates guidance to speed up drug development

June 22 (Reuters) - The U.S. Food and Drug Administration said on Monday it is launching a series of measures to speed up ...
STAT

FDA drops enforcement against Whoop after it tweaks blood pressure feature

The FDA told wearable maker Whoop last week that it would not take further enforcement action over the company's blood ...
JD Supra

FDA to Limit PFAS in Bottled Water, FDA Denies Citizen Petition for PFAS Food Tolerances, and California EPR Law Challenged.

The U.S. Food & Drug Administration (FDA) has announced plans to regulate per- and polyfluoroalkyl substances (PFAS) in bottled water. The decision stems from a requirement under the Federal Food, ...

Memphis Surgeon Seeks to Overturn Conviction, Citing FDA Guidance on Medical Devices with National Experts Aghast at Overzealous Persecution Despite FDA Safe Harbor

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 ...
Regulatory Affairs Professionals Society

FDA revises master protocol guidance with new section on basket trials

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...
RAPS

FDA Law and Regulation

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 ...
Healthline

Which Products Does the FDA Regulate?

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...
MD&M East

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Medical device manufacturers that want to avoid a long deficiency letter will want to pay close attention to FDA’s final cybersecurity guidance, updated in June 2025 (and again in February 2026).

FDA says Amazon violated federal regulations with sale of unapproved penile creams

The federal agency purchased three creams through Amazon's website. The FDA described all three as unapproved drugs that are ...