The FDA Just Updated Its Guidance for Bagged Lettuce, Cut Fruit, and Other Ready-to-Eat Produce

Because fresh-cut produce doesn’t undergo a final step to eliminate harmful pathogens, the agency’s recommendations emphasize ...
STAT

New guidelines on migraine prevention reflect increasing options for patients

There has been a wealth of new treatment available” for migraine prevention, said a co-author of new guidelines released ...
Healio

FDA issues draft guidelines for non-opioid solutions to chronic pain

Please provide your email address to receive an email when new articles are posted on . The guidelines address issues related to development and prescription of non-opioid pain drugs. They are part of ...
STAT

FDA digital health leader promises generative AI regulatory guidance is coming

FDA expects to issue guidance on policies regarding generative AI devices, according to Rick Abramson, the agency’s head of ...
JD Supra

FDA Revises Draft Guidance on Substantial Evidence of Effectiveness to Clarify Confirmatory Evidence Requirements for a Single Clinical Investigation

On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating ...
Food Safety News

New FDA guidance in the works for 2025

The FDA has published its proposed agenda for 2025 guidance, including new topics such as food colorings. Topics on the agenda are a priority for the Food and Drug Administration’s Human Foods Program ...
Regulatory Affairs Professionals Society

Industry asks FDA to expand prior knowledge guidance

Industry stakeholders want the US Food and Drug Administration (FDA) to expand the scope of its recent draft guidance on the ...
FiercePharma

FDA finalizes guidance on promotional materials for biologics and biosimilars

A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...
Regulatory Affairs Professionals Society

FDA drafts guidance on assessing impact of hepatic impairment on drug PK/PD

The US Food and Drug Administration (FDA) has published a draft guidance on how to design trials and analyze data from ...
JD Supra

FDA’s New Psychedelic Drug Guidance Paves a Path to Approval While Setting a High Evidentiary Bar

On July 13, 2026, the U.S. Food and Drug Administration (“FDA” or “Agency”) finalized its guidance on “Psychedelic Drugs: Considerations for Clinical Investigations,” replacing the June 2023 draft ...
Washington Post

FDA to issue new vaccine approval guidance amid questions over coronavirus shots

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 ...

FDA panel recommends loosening regulations for some peptides

The FDA panel is reviewing seven peptides and deciding if they should be added to a list of substances that can be safely produced by compounding pharmacies.