News & Analysis as of

Final Rules New Guidance Food and Drug Administration (FDA)

Akin Gump Strauss Hauer & Feld LLP

FDA Grants Three Natural Food Additive Petitions

On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing approval. These approvals come after the agency’s announcement last...more

McDermott Will & Emery

End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...more

Wiley Rein LLP

FDA Updates Final Guidance on Cosmetic Facility Registration and Product Listing: Wiley

Wiley Rein LLP on

The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more

Hogan Lovells

FDA issues Guidance on Interim Animal Food Ingredient Consultation (AFIC) Process

Hogan Lovells on

On January 6, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) issued its final guidance on the interim Animal Food Ingredient Consultation (AFIC) process, which FDA positions as a...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Jones Day on

As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

Foley Hoag LLP

FDA’s Major Statement: The Agency’s Recent Direct-to-Consumer CCN Final Rule, Q&A Guidance and Enforcement Trends

Foley Hoag LLP on

On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more

Davis Wright Tremaine LLP

FDA Issues Small Entity Compliance Guidance for Yogurt Standard of Identity

SOI sets new requirements for labels and ingredients, including for minimum dairy amount and bacterial cultures; compliance deadline is January 1, 2024 The U.S. Food and Drug Administration (FDA) announced the availability...more

King & Spalding

FDA Issues New Draft Guidance for Sponsors on Safety Event Analysis and Reporting for IND and Bioavailability/Bioequivalence...

King & Spalding on

Focuses on Aggregate Safety Data Analysis and Expedited Reports; Expectation for Prospective Safety Surveillance Plan - The Food and Drug Administration (FDA) has issued a new draft guidance (the Draft Guidance) that...more

Mintz - Health Care Viewpoints

With Release of New Guidance, FDA Signals It’s Serious About Enforcing Clinical Trial Data Requirements

Clinical trial sponsors and principal investigators can consider themselves on notice that the Food & Drug Administration (FDA) is poised to ramp up enforcement activity relating to responsible parties’ obligations regarding...more

BCLP

FDA Provides Guidance for New Nutrition and Supplement Facts Labels

BCLP on

On November 5, the FDA released non-binding guidance intended to answer questions related to Nutrition Facts and Supplement Facts Label and Serving Size final rules. As we previously reported, the rules were finalized in May...more

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

Verrill on

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

McNees Wallace & Nurick LLC

New Industry Resources for FDA’s New Nutrition Facts Regulations

The U.S. Food and Drug Administration (FDA) published a Nutrition Facts label “Industry Resources” web page to help businesses comply with the requirements of the final rules, which became effective on July 26, 2016....more

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