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FDA Revises Draft Guidance on Substantial Evidence of Effectiveness to Clarify Confirmatory Evidence Requirements for a Single Clinical Investigation

On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating ...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

How Lipfendra, Inclisiran, and New Guidelines Are Changing Cholesterol Management

A promising new therapy, the FDA approval of Lipfendra, and updated cholesterol guidelines are expanding treatment options for people with high LDL cholesterol. Here's what these recent developments ...
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 ...
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 ...
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 ...
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 ...

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 ...

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 ...
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 ...
RAPS

FDA drafts guidance on best practices for responding to inspection observations

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.
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 ...
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 ...