RAPS

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The US Food and Drug Administration (FDA) has published a draft guidance on how to design trials and analyze data from ...

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

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

Key FDA Updates: Substantial Evidence, Gene Therapy Development and AI-Enabled Early-Phase Clinical Trials

On June 24, 2026, the U.S. Food and Drug Administration (FDA) released a draft update to its 2019 draft guidance titled “Demonstrating ...
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 ...
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FDA Revises Draft Guidance on Substantial Evidence of Effectiveness to Clarify Confirmatory Evidence Requirements for a Single Clinical Investigation

On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating ...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

FDA’s 2025 Food Agenda: What industry must know

FDA’s recently unveiled 2025 Human Foods Program guidance agenda offers a detailed view of the agency’s priorities for the year ahead. The document is non-binding, but provides critical insight into ...
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 ...
MD&M East

FDA Clarifies When Software & Wellness Products Are Not Medical Devices

Medical device manufacturers developing digital health products face a recurring question: Will the U.S. Food and Drug Administration (FDA) regulate this product? Many digital health products can ...
Fox News

Trump administration to unveil new dietary guidelines as FDA plans sweeping 2026 food overhaul

The Trump administration is preparing to roll out new dietary guidelines for Americans in early January, a move Food and Drug Administration (FDA) officials say will kick off a broader food policy ...

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.