Regulatory Affairs Professionals Society

FDA finalizes Q&A guidance on developing cell and gene therapies

The US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to ...
RAPS

FDA finalizes guidance on formal meetings with drug and biologics sponsors

The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and ...

US FDA finalizes new guidance on freshly cut produce

Aug 11 (Reuters) - The U.S. Food and Drug Administration on Tuesday finalized guidance for companies that prepare and package ...
Food Safety News

FDA issues guidance for producers of fresh-cut product

The FDA has published guidance with information for manufacturers and processors of ready-to-eat produce to help them comply ...
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FDA Revises Draft Guidance on Substantial Evidence of Effectiveness to Clarify Confirmatory Evidence Requirements for a Single Clinical Investigation

On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating ...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

Premarket Review of AI Medical Devices: FDA Hints at Larger Role for Regulatory Tool that Predicts How A Device May Learn and Evolve

Traditionally, the Food & Drug Administration’s (“FDA”) premarket review of medical devices assumes devices are static. A product is ...

FDA proposes new regulations on food ingredients

The FDA proposed a new rule on Monday calling for food companies to disclose the addition of new ingredients in their ...
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 ...

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.
The American Journal of Managed Care

FDA Guidance to Remove One of the Largest Barriers to Biosimilar Development

The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...
MD&M East

FDA’s AI Device Regulations: Key Updates & Compliance Strategies for Medtech Success

FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing ...