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Healthcare › Regulatory Oversight › Public Health

Sheppard Mullin Richter & Hampton LLP

New York Adopts Major Certificate of Need Amendments Effective August 6, 2025

Sheppard Mullin Richter & Hampton LLP on

On August 6, 2025, the New York State Department of Health (DOH) finalized amendments to its Certificate of Need (CON) regulations in 10 N.Y.C.R.R. Part 710, raising the financial thresholds for full review, expanding...more

Kerr Russell

What Causes a LARA Investigation?

Kerr Russell on

Question: Over the years, several of my colleagues and I have been the subject of investigations by the Michigan Department of Licensing and Regulatory Affairs. In most of these cases it’s hard to imagine why LARA is...more

Holland & Knight LLP

Proposed Changes to New York's Material Transactions Law Expand Oversight

Holland & Knight LLP on

New York Gov. Kathy Hochul unveiled her executive budget proposal for State Fiscal Year (FY) 2025-2026 on Jan. 21, 2025, which includes amendments to the state's Disclosure of Material Transactions law. If the amendments are...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - November 2023 #1

Arnall Golden Gregory LLP on

News Briefs - Biden Executive Order Aims to Bolster AI Security in Healthcare - The Biden Administration issued what it's calling a "landmark" executive order designed to help channel the significant promise and manage the...more

Stevens & Lee

New York Enacts Notice Requirements for Material Health Care Transactions but Removes Approval Authority

Stevens & Lee on

On May 3, 2023, New York Governor Kathy Hochul signed into law an amendment (the “Amendment”) to the New York Public Health Law, effective on or about August 1, 2023, that will require certain Healthcare Entities to provide...more

Hogan Lovells

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

Hogan Lovells on

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for comment.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

Hogan Lovells on

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

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal...

Hogan Lovells on

The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more

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