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Regulatory Reform › Life Sciences › Enforcement Actions

Troutman Pepper Locke

2025 Mid-Year Review: State AGs in a New Era

Troutman Pepper Locke on

The United States is navigating a new era of regulatory oversight and the balance of power between federal and state regulators following the 2024 election cycle. As federal agencies retreat from and/or realign their...more

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

Skadden, Arps, Slate, Meagher & Flom LLP on

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

Cozen O'Connor

FDA Bans Red Dye No. 3 in Food and Ingested Drugs: What Manufacturers Should Know

Cozen O'Connor on

On January 16, 2025, the Food and Drug Administration (FDA) issued an order banning FD&C Red No.3 in food and ingested drugs.1 Food and ingested drug manufacturers who use Red No. 3 have until January 15, 2027, or January 18,...more

Jones Day

China Finalizes Its First Anti-Corruption Guidelines for the Health Care and Life Sciences Industry

Jones Day on

On January 14, 2025, China's State Administration for Market Regulation ("SAMR"), the primary regulatory agency in China for overseeing market supervision, issued its Compliance Guidelines for Health Care Companies to Prevent...more

Jones Day

DOJ Rescinds Limits on the Use of Agencies' Guidance Documents in Civil Enforcement Actions

Jones Day on

A recent action by the Department of Justice ("DOJ") rescinds two prior policies (commonly referred to as the Brand Memo and the Sessions Memo) that had established limits on the federal government's use of agency guidance...more

Morgan Lewis

What the Future May Hold for Pharma Regulation Under the Biden Administration

Morgan Lewis on

Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....more

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