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Public Health Manufacturers

Carlton Fields

Executive Order Seeks to Build Resilience in Pharmaceutical Supply Chains

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On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more

Cozen O'Connor

FDA Encourages Food Manufacturers to Phase Out FD&C Red No. 3 Ahead of 2027 Deadline

Cozen O'Connor on

On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.” Recall...more

Morgan Lewis - As Prescribed

FDA’s New Priority Voucher Program for Drug Developers Ties Incentives to Defined National Interests

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors...more

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

Foley Hoag LLP on

Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

Sheppard Mullin Richter & Hampton LLP

HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program

On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which...more

Farella Braun + Martel LLP

Legislation Banning “Forever Chemicals” in Food Packaging in California by 2028 Will Likely Become Law

The California Senate recently passed a bill, SB 682, that would essentially eliminate the use of per-and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” in food packaging within the state, as of January...more

Perkins Coie

Louisiana and Texas Enact New Laws Regarding Food Ingredient Disclosures and School Nutrition

Perkins Coie on

Louisiana and Texas recently enacted new legislation imposing disclosure requirements on food and beverage manufacturers, as well as new restrictions on ingredients permitted in public school meals. Some changes take effect...more

Haynes Boone

Louisiana to Require Disclosures of Specified Food and Color Additives

Haynes Boone on

Now the law in Louisiana, Senate Bill 14 (S.B. 14) not only prohibits certain food ingredients in school-provided meals and beverages, but also requires food manufacturers to disclose the presence of certain food additives...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

BakerHostetler on

Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

Gardner Law

The Value of MDUFA

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Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more

Venable LLP

FDA Regulatory Updates for Summer 2025: Food, Supplements, and Cosmetics

Venable LLP on

Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be...more

Cozen O'Connor

Bipartisan Coalition of AGs Secures $720 Million Settlement with Opioid Manufacturers

Cozen O'Connor on

Virginia AG Jason Miyares, along with a bipartisan coalition of eight other AGs, announced a $720 million settlement with eight opioid drug manufacturers to resolve allegations that they contributed to the opioid epidemic....more

Gardner Law

FDA Signals Interest in Defining Ultraprocessed Foods

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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

Akin Gump Strauss Hauer & Feld LLP

FDA Green Lights Another Natural Food Color

This week, the U.S. Food and Drug Administration (FDA) granted another color additive petition, approving the use of Gardenia (Genipin) in various food and beverage products. This marks the fourth naturally-derived color...more

Holland & Knight LLP

Red Flags Over Red 40: Heightened Regulatory Scrutiny on Use of Artificial Food Dyes

Holland & Knight LLP on

The regulatory landscape for consumer-packaged goods (CPG) brands is shifting, with artificial food dyes emerging as a central focus of both state and federal scrutiny. Recent actions by the federal and state governments,...more

MG+M The Law Firm

PCBs and Precedent: What the Monsanto Settlement Means for Future Toxic Torts - (UPDATED)

MG+M The Law Firm on

Monsanto has recently settled with families who claimed they were exposed to polychlorinated biphenyls (PCBs) at a school near Seattle, ending what had become one of the most closely watched toxic tort cases in recent memory....more

Cozen O'Connor

All AGs Settle with Purdue Pharma over Opioid-Related Claims

Cozen O'Connor on

All 55 AGs from the states and territories have settled with Purdue Pharma, Inc., and its owners, members of the Sackler family, to resolve allegations related to the company’s role in fueling the opioid crisis....more

MG+M The Law Firm

Bitter Aftertaste: PFAS Found in US Beer

MG+M The Law Firm on

The Environmental Science & Technology Journal found in a 2025 study that 95% of 23 tested beers brewed across the United States contain varying levels of per- and polyfluoroalkyl substances (PFAS). PFAS are synthetic...more

Morris James LLP

Analyzing the Impact of Recent Studies Linking Depo-Provera to Increased Meningioma Risk

Morris James LLP on

Recent scientific research has uncovered a significant association between the long-term use of Depo-Provera, a widely used injectable contraceptive, and the development of meningiomas, tumors affecting the membranes...more

Jones Day

Georgia Limits Liability for Pesticide Manufacturers

Jones Day on

This week, Georgia's governor signed a new pesticide labeling and liability act (SB 144) ("Act"), amending state law to limit the scope of pesticide manufacturer liability for failure to warn and aligning the state standards...more

Troutman Pepper Locke

PFAS Regulatory Landscape Update — The Message? Stay Tuned.

Troutman Pepper Locke on

The Environmental Protection Agency (EPA) has announced several actions in recent weeks that shed light on the Trump administration’s approach to PFAS regulation....more

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Venable LLP

FDA Launches Operation Stork Speed to Make Infant Formula Healthy Again

Venable LLP on

On March 18, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced the launch of Operation Stork Speed “to enhance [FDA’s] efforts to ensure the ongoing quality, safety,...more

Mitchell, Williams, Selig, Gates & Woodyard,...

PFAS Liability/Drinking Water Exceedances: Legislation Submitted to North Carolina General Assembly Allocating Liability

House Bill 569 has been submitted to the General Assembly of North Carolina which is styled: AN ACT TO PROTECT THE CITIZENS OF NORTH CAROLINA FROM DRINKING WATER CONTAMINATED BY GENX AND OTHER PFAS COMPOUNDS....more

Knobbe Martens

U.S. Supreme Court Defers to Agency Decision-Making in FDA’s Denial of Premarket Approval of Flavored E-Cigarette Products

Knobbe Martens on

We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product. On April 2, 2025, the Supreme Court of the United States...more

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