Life Sciences Post-Chevron: Navigating the Range of Legal and Regulatory...
The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, which overrules the longstanding Chevron doctrine that required federal courts to defer...
View ArticleFDA Issues Guidance on Foods Made from Genome-Edited Plants in Newest Update...
The US Food and Drug Administration (FDA) issued final guidance titled Foods Derived from Plants Produced Using Genome Editing (Genome-Edited Plants Guidance), describing the agency’s approach for...
View ArticleThe Horse Is Out of the Barn: FDA and AAFCO Memo of Understanding on Animal...
The Association of American Feed Control Officials (AAFCO) and the US Food and Drug Administration (FDA) announced on August 2, 2024 that their long-standing Memorandum of Understanding (MOU) governing...
View ArticleFood Safety 3.0: FDA Implements Human Foods Program Alongside Long-Awaited...
On October 1, 2024, the US Food and Drug Administration (FDA) announced the implementation of its long-promised reorganization, with the establishment of the unified Human Foods Program (HFP). The HFP...
View ArticleHow the US Election May Affect the FDA Regulation of Life Sciences Products –...
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question...
View ArticleFDA Cosmetic Updates: New Q&As for MoCRA Facility Registration, Product...
FDA continues to construct its regulatory program for cosmetic products, albeit at a slower pace than the congressional timelines provided in the Modernization of Cosmetics Regulation Act of 2022...
View ArticleNavigating FDA from 2024 into 2025 Human Foods Program
FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food industry change in 2024 was the overhaul of how FDA structures itself to...
View ArticleThe Future of Artificial Colors in the US Food Supply Is Not So Bright
Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with...
View ArticleKey Considerations for Foreign Clinical Trials When Looking Abroad for...
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development...
View ArticleFDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug...
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to...
View ArticleHHS Signals GRAS Reform: How Food Manufacturers Can Prepare Now
Ingredient suppliers and food manufacturers face an uncertain supply chain landscape in which “generally recognized as safe” (GRAS) self-determinations may be more closely scrutinized. The US...
View ArticleFDA Drug Inspections Post–Workforce Reductions: Potential Implications and...
The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time...
View ArticleProposed Nutrition and Allergen Labeling Changes for Alcoholic Beverages: Key...
The Alcohol and Tobacco Tax and Trade Bureau (TTB) has published a pair of proposed rules that if finalized could significantly reshape alcohol beverage labeling in the United States. In a move aimed...
View ArticleFrom Offshore to Onshore: Considerations for Pharmaceutical Industry...
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while...
View ArticleState Legislation on Color Additives in Food: Takeaways for Industry
Both state and federal government authorities have recently turned their attention toward artificial coloring in foods. The Food and Drug Administration (FDA) announced a series of measures in April...
View ArticleFood for Thought Implications of FDAs New Chemical Review Program
The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more...
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