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Regulatory Agenda Regulatory Oversight Healthcare

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

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The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

McGuireWoods LLP

Texas House Bill 3749 Proposes Stricter Regulations for Medical Spas

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As the medical spa industry rapidly expands, states are increasing regulatory oversight to ensure patient safety and compliance with medical standards. Texas is the latest state to propose legislation targeting med spas,...more

Quarles & Brady LLP

Alabama Bill Proposes Rewrite of Pharmacy Practice Act

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The future direction of the Alabama Board of Pharmacy (“the Board”) hangs in the balance following recent legislation that, if passed, would revise many portions of the state Pharmacy Practice Act. House Bill 123, sponsored...more

Foley Hoag LLP - White Collar Law &...

New Massachusetts Healthcare Law Targets Private Equity, REITs, and MSOs; Expands State False Claims Act

On January 8, 2025, Governor Maura Healey signed House Bill 5159 into law, toughening the rules and increasing the risks for private equity (PE) companies, real estate investment trusts (REITs), and management services...more

Foley & Lardner LLP

Artificial Intelligence in Health Care: Key Considerations for Oncology

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Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions. This hot topic was...more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

Sheppard Mullin Richter & Hampton LLP

Illinois Proposes Heightened Oversight for Healthcare Transactions

Starting January 1, 2024, healthcare facilities and provider organizations engaging in certain transactions in Illinois, such as mergers and acquisitions, will have new reporting requirements. Illinois recently joined a...more

Seyfarth Shaw LLP

The Week in Weed: October 2023 # 2

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Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we see Georgia pharmacies selling medical marijuana. We have an update on the Ohio legalization ballot...more

ArentFox Schiff

Legislative Developments in AI: The Bipartisan Framework for the US AI Act

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On September 12, 2023, the Senate Judiciary Subcommittee on Privacy, Technology, and the Law convened a hearing to discuss potential legislation focused on AI models, the third in a series of hearings by the subcommittee...more

Robinson+Cole Health Law Diagnosis

New York Proposes Regulatory Overhaul for HealthCare Transactions with a Focus on Investor-Backed Healthcare Transactions

Proposed legislation from the New York State Executive Budget for 2024 includes significant changes to the state’s regulatory approach and authority over healthcare transactions.  New York is following a trend on the state...more

Robinson+Cole Health Law Diagnosis

California Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities Statewide

On June 30, 2022, Governor Gavin Newsom signed the 2022-2023 California state budget, which included a trailer bill, Senate Bill 184 (the Bill) which makes numerous statutory revisions impacting health programs and consumers....more

Nelson Mullins Riley & Scarborough LLP

FDA Concludes Software Pre-Cert Pilot Program, Noting Federal Legislative Action is Needed

The U.S. Food and Drug Administration (“FDA” or the “Agency”) has issued a final report discussing the results of its Software Precertification Pilot Program (the “Pilot Program”). Importantly, the September 26, 2022 report...more

Mintz - Health Care Viewpoints

Device Modernization Series: In Vitro Clinical Tests

In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory...more

Hogan Lovells

FDA’s Bendeka decision reverses approvals of Treanda generics

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Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more

Hogan Lovells

FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483

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On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for comment. ...more

Hogan Lovells

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

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The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019.  Unfortunately, FDA is one of the agencies with at least some...more

Hogan Lovells

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

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Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

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