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Dec 10, 2024 | 
jdsupra.com | Michele L. Buenafe |Andrew Gray IV |Jacob Harper
The Artificial Intelligence in Healthcare Services Bill, signed into law by Governor Gavin Newsom, imposes new requirements on California healthcare providers that use generative artificial intelligence tools to generate patient communications. This law introduces new guardrails for California healthcare providers that deploy GenAI to reach their patients and is part of a broader effort by California to regulate the rapidly growing generative artificial intelligence (GenAI) sector.
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Dec 9, 2024 | 
morganlewis.com | Michele L. Buenafe |Jacob Harper |Nicholas Pfeiffer
The Artificial Intelligence in Healthcare Services Bill, signed into law by Governor Gavin Newsom, imposes new requirements on California healthcare providers that use generative artificial intelligence tools to generate patient communications. This law introduces new guardrails for California healthcare providers that deploy GenAI to reach their patients and is part of a broader effort by California to regulate the rapidly growing generative artificial intelligence (GenAI) sector.
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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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Nov 12, 2024 | 
jdsupra.com | Jacqueline R. Berman |Michele L. Buenafe |Rebecca Dandeker
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 impact the regulation of drugs, devices, and other life sciences products by FDA and related regulators.
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Nov 8, 2024 | 
morganlewis.com | Jacqueline R. Berman |Michele L. Buenafe |Rebecca Dandeker |Dennis Gucciardo
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 impact the regulation of drugs, devices, and other life sciences products by FDA and related regulators.
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Oct 11, 2024 | 
jdsupra.com | Michele L. Buenafe |Dennis Gucciardo
With the February 2, 2026 compliance deadline approaching, medical device manufacturers must prepare for FDA’s updated regulations. The new Quality Management System Regulation (QMSR) will replace the existing Quality System Regulation (QSR), aligning with ISO 13485:2016. The transition may bring significant change to manufacturers not already compliant to ISO 13485:2016. On February 2, 2026, medical device manufacturers must fully comply with FDA’s revamped regulations at 21 C.F.R. Part 820.
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Oct 10, 2024 | 
morganlewis.com | Dennis Gucciardo |Michele L. Buenafe
With the February 2, 2026 compliance deadline approaching, medical device manufacturers must prepare for FDA’s updated regulations. The new Quality Management System Regulation (QMSR) will replace the existing Quality System Regulation (QSR), aligning with ISO 13485:2016. The transition may bring significant change to manufacturers not already compliant to ISO 13485:2016. On February 2, 2026, medical device manufacturers must fully comply with FDA’s revamped regulations at 21 C.F.R. Part 820.
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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 | 
jdsupra.com | Jacqueline R. Berman |Michele L. Buenafe |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.
