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 ...
JD Supra

The FDA Finalizes Guidance on Formal Meetings for Drug and Biologic Development

On August 13, 2026, the FDA (Center for Drug Evaluation and Research (“CDER”) and Center for Biologics Evaluation and Research (“CBER”)) issued ...
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 ...
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 ...
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 ...
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Industry stakeholders want the US Food and Drug Administration (FDA) to expand the scope of its recent draft guidance on the ...
Regulatory Affairs Professionals Society

Industry, patient groups seek changes to FDA’s revised master protocols guidance

Industry and patient groups have asked the US Food and Drug Administration (FDA) to make several changes to its revised draft ...
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 ...
Healio

FDA-identified uncertainties about new cancer drugs often omitted in journals, guidelines

Please provide your email address to receive an email when new articles are posted on . The FDA frequently identifies uncertainties about newly approved cancer drugs, but they are often omitted in ...
CNBC

FDA proposes new system for approving customized drugs and therapies for rare diseases

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...