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AI at the FDA: help or hindrance?

The advent of AI at the US Food and Drug Administration (FDA) is changing the complexion of the regulatory approval process for medical devices. In May, FDA commissioner Dr Martin Makary announced ...
RAPS

Senate HELP chair proposes reforms to FDA’s regulatory framework

The top lawmaker on the Senate Health, Education, Labor, and Pensions (HELP) Committee published a report this week on reforming the US Food and Drug Administration (FDA). The report argues the ...
RAPS

Nature Editorial: FDA Needs Help Assessing Cutting-Edge Tech

The US Food and Drug Administration (FDA) is increasingly being tasked with evaluating cutting-edge therapies and technology that its in-house expertise may not be able to address, according to a ...
Business Insider

FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance to help developers bring promising gene therapies to patients more ...
CNN

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
Food Safety News

FDA wants to delay key rule that would help investigators during foodborne outbreaks

The FDA plans to delay the compliance date for traceability regulations for food by more than two years. The move comes at the request of food companies. The traceability rule is part of the Food ...