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Food and Drug Administration (FDA) › Regulatory Reform › Draft Guidance

Gardner Law

FDA Guidance for Labeling Plant-based Products

Gardner Law on

The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...more

Ropes & Gray LLP

FDA Issues Draft Guidance Describing When a Confirmatory Trial of a Drug Seeking Accelerated Approval Is “Underway”

Ropes & Gray LLP on

In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more

Foley Hoag LLP

Want to Say It Ain't So? FDA Guides Firms on How to Respond to Misinformation

Foley Hoag LLP on

Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more

Perkins Coie

Dietary Supplements: FDA Issues Draft Guidance on NDIN Master Files

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On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how stakeholders can...more

McDermott Will & Schulte

FDA Releases Final Guidance on New Dietary Ingredient Notification Procedures and Timeframes

McDermott Will & Schulte on

On March 5, 2024, the US Food & Drug Administration (FDA) released final guidance titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance is meant to...more

Perkins Coie

Food Allergen Programs and Acidified Foods: FDA Adds Two New Chapters to its Draft Guidance on Preventive Controls for Human Food

Perkins Coie on

On September 26, 2023, the U.S. Food & Drug Administration (FDA) added two new chapters to the agency’s draft guidance (the Draft Guidance): Chapter 11: Food Allergen Program and Chapter 16: Acidified Foods. These additions...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

Nelson Mullins Riley & Scarborough LLP

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more

Hogan Lovells

FDA loosens restrictions on gynecologic power morcellators, recommends use only with containment

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an update to safety communications...more

Knobbe Martens

FDA Issues Draft Guidance for "Least Burdensome” Approach to Device Regulation

Knobbe Martens on

The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.”  The FDA provides this draft guidance...more

Jones Day

FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products

Jones Day on

The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more

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