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2 months ago | 
jdsupra.com | Kathleen M. Sanzo
FDA Restructures its Food ResourcesAlthough 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 regulate foods generally. In October, FDA eliminated the Center for Food Safety and Applied Nutrition and created the Human Foods Program. Under the new structure, food policy and response functions and field operations are combined to provide a more holistic regulatory platform on which to regulate foods.
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Dec 23, 2024 | 
jdsupra.com | Kathleen M. Sanzo
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 (MoCRA). FDA has yet to provide explanatory guidance on several congressionally mandated items including fragrance allergen disclosures, product safety substantiation, and serious adverse event reporting.
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Nov 14, 2024 | 
law360.com | Jacqueline R. Berman |Michele L. Buenafe |Kathleen M. Sanzo
By Jacqueline Berman, Michele Buenafe and Kathleen Sanzo ( November 14, 2024, 6:41 PM EST) -- 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 how this political shift may affect the regulation of drugs, devices and other life sciences products by the U.S. Food and Drug Administraiton and related regulators....
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Nov 14, 2024 | 
law360.co.uk | Jacqueline R. Berman |Michele L. Buenafe |Kathleen M. Sanzo
By Jacqueline Berman, Michele Buenafe and Kathleen Sanzo ( November 14, 2024, 6:41 PM EST) -- 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 how this political shift may affect the regulation of drugs, devices and other life sciences products by the U.S. Food and Drug Administraiton and related regulators....
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Sep 24, 2024 | 
morganlewis.com | Michael Abernathy |Stephen Altieri |Louis W. Beardell |Jacqueline R. Berman |Olga Berson |Christopher J. Betti | +23 more
NEW YORK, September 24, 2024: Morgan Lewis has received 13 practice rankings and 27 individual lawyer recognitions in the 2024 edition of Legal Media Group’s (LMG) LMG Life Sciences guide, an annual guide that honors law firms and lawyers for outstanding work in life sciences.
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May 23, 2024 | 
morganlewis.com | Kathleen M. Sanzo |Michele L. Buenafe |Jacqueline R. Berman |Alexandre Gapihan
On May 21, 2024, The Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking in the Federal Register (FR) to reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). This announcement comes nearly a year after the US Department of Health and Human Services (HHS) August 29, 2023 letter to the DEA recommending that marijuana be rescheduled.
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Apr 5, 2024 | 
morganlewis.com | Kathleen M. Sanzo |Stephanie Feingold |Alexandre Gapihan |Maria Kalousi-Tatum
The US Food and Drug Administration (FDA) recently announced that manufacturers have completed the voluntarily phase-out of the use of certain per- and polyfluoroalkyl substances (PFAS) in grease-proofing agents for food packaging. PFAS consist of a large group of synthetic chemicals that have been used widely in consumer products and industrial processes since the 1950s for a broad range of uses, including to keep food from sticking to cookware or packaging, or make clothes resistant to stains.
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Mar 6, 2024 | 
jdsupra.com | Alexandre Gapihan |Maria Kalousi-Tatum |Kathleen M. Sanzo
The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two diabetes if the claims are not misleading and comply with other regulatory requirements. In general, a health claim describes the link between a substance and its impact on health or disease (e.g., sodium and hypertension).
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Mar 5, 2024 | 
morganlewis.com | Kathleen M. Sanzo |Alexandre Gapihan |Maria Kalousi-Tatum
The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two diabetes if the claims are not misleading and comply with other regulatory requirements. In general, a health claim describes the link between a substance and its impact on health or disease (e.g., sodium and hypertension).
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Mar 1, 2024 | 
morganlewis.com | Jami McKeon |Kathleen M. Sanzo
WASHINGTON, DC, March 1, 2024: Bolstering its capabilities for companies in the life sciences industry, Morgan Lewis today welcomes Stephen Forster, who most recently served as senior director and lead counsel of pricing and commercial access strategy at Otsuka Pharmaceutical. As a partner resident in Washington, DC, Steve will advise life sciences companies on drug pricing and commercial contracting matters.
