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New Regulations › Manufacturers › Food and Drug Administration (FDA)

BakerHostetler

FDA’s ‘PreCheck’ Program: New Pathway to Acceleration of US Drug Manufacturing

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The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. ...more

Gardner Law

FDA Signals Interest in Defining Ultraprocessed Foods

Gardner Law on

In June 2025, the U.S. Food and Drug Administration announced it is evaluating whether to formally define the term ultraprocessed food (UPF)—a move that could influence future labeling regulations, public health guidance, and...more

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

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In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Gardner Law

Staying Prepared Amid FDA Changes

Gardner Law on

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Arnall Golden Gregory LLP

Surprise, Surprise: FDA Announces Plans to Increase Number of Unannounced Inspections at Foreign Manufacturing Facilities

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In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more

Environmental General Counsel PC

CalRecycle Releases New EPR Packaging Regulations: Imminent Compliance, New Exclusions, and Deferred Eco-Modulation Implementation

Environmental General Counsel PC on

A lot is going on in the extended producer responsibility (“EPR”) packaging world this month.  Maryland and Washington became the sixth and seventh states respectively to enact EPR packaging laws.  And this week, just a...more

Hogan Lovells

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

Hogan Lovells on

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more

Shook, Hardy & Bacon L.L.P.

FDA, HHS Announce Measures to Phase Out Petroleum-Based Dyes in Food

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The U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) have announced actions to phase out petroleum-based synthetic dyes from foods in the U.S. food supply. In a news release, FDA said...more

Troutman Pepper Locke

FDA’s New Lead Guidelines: A Milestone for Safer Baby Foods

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In recent years, the safety of baby food has become a top priority for state attorneys general (AG) and federal agencies. In April 2021, the U.S. Food and Drug Administration (FDA) announced its “Closer to Zero” plan to...more

Perkins Coie

FDA and AAFCO Updates for Animal Food Ingredient Oversight

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FDA’s Center for Veterinary Medicine (CVM) recently announced the upcoming expiration of its longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO). This MOU—which has...more

Perkins Coie

Oregon Finalizes New Regulations To Implement Psilocybin Services Act

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Oregon became the first state to offer controlled use of psilocybin to the public on January 1, 2023. Psilocybin is a Schedule I psychoactive substance that is illegal at the federal level. Notwithstanding this federal...more

Foley Hoag LLP

Congress Adds Some Teeth to FDA’s Authority to Regulate Cosmetics

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The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more

King & Spalding

Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics

King & Spalding on

The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more

Seyfarth Shaw LLP

FDA Eases Enforcement to Expand Remote Care of Pets and Food-Producing Animals

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On March 24, 2020, the US Food and Drug Administration (“FDA”) issued Guidance[1] suspending the enforcement of certain veterinarian-client-patient relationship (“VCPR”) requirements to help veterinarians provide animal...more

Mintz - Health Care Viewpoints

Paradigm Shift: Regulating Software as a Medical Device in the U.S.

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The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety...more

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