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

A former AI regulator, now in industry, says biopharma is reading FDA’s guidance wrong

Companies are being too conservative in how they interpret FDA's AI guidance, but the agency can do more to help, too, Tala ...
Regulatory Affairs Professionals Society

This Week at FDA: FDA names PreCheck participants, TAP open to all OHT devices, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
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The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...

FDA launches pilot program to speed up early drug trials

The agency says pairing drug sponsors with research institutions could cut development timelines by 6 to 12 months ...
Life Science Leader

Understanding FDA's Plausible Mechanism Framework For Genetic Medicines

FDA’s draft “plausible mechanism” framework gives individualized genetic therapies a clearer path to market, but questions remain, write experts at Morrison Foerster.

From Caffeine To 'Healthy' Labeling, FDA Sets Year-End Agenda For US Food Supply

For example, the FDA plans to draft guidance on action levels for cadmium and inorganic arsenic in food products meant for ...

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 ...
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, ...
MobiHealthNews

Recent FDA guidances cover software changes, real world evidence, wellness devices

The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices.
MobiHealthNews

New FDA guidances aim to increase clarity on when developers need to resubmit 510(k)s

The FDA released two final guidances and a new draft guidance today to increase the regulatory clarity around medical devices, including software as a medical device. The agency also announced the ...