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Healthcare New Guidance Public Health

Alston & Bird

Health Care Week in Review | HHS Cancels mRNA Vaccine Development Projects Under BARDA; President Trump Signs EO to Increase...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Holland & Knight LLP

New York State Department of Health Issues Long-Awaited Guidance on Material Transactions Law

Holland & Knight LLP on

The New York State Department of Health (DOH) has published a set of Frequently Asked Questions (FAQs) to provide guidance on the "Disclosure of Material Transactions" law that took effect on Aug. 1, 2023. Pursuant to Article...more

Akin Gump Strauss Hauer & Feld LLP

FDA Unveils Draft Guidance on Developing Drugs and Biological Products for Weight Reduction

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Foley Hoag LLP - Security, Privacy and the...

CISA Publishes Mitigation Guide to Combat Cyber Threats in the Healthcare and Public Health Sectors

If you need a little intellectual stimulation after hours of Thanksgiving turkey and football, the U.S. Cybersecurity and Infrastructure Security Agency (CISA) has just the thing — the new CISA Mitigation Guide for the...more

Robinson+Cole Health Law Diagnosis

CMS Issues Guidance for Providers on Waivers, Flexibilities and End of COVID-19 Public Health Emergency

The Centers for Medicare & Medicaid Services (CMS) recently issued a Fact Sheet (Fact Sheet) providing guidance on the impact of the end of the federal COVID-19 Public Health Emergency (PHE) on certain regulatory waivers,...more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

UB Greensfelder LLP

US to Relax Travel Restrictions On Fully Vaccinated Foreign Visitors

UB Greensfelder LLP on

The White House announced today that the United States plans to lift the geographic based travel restrictions on fully vaccinated foreign visitors starting this November. This new guidance will apply to all international...more

Robinson+Cole Health Law Diagnosis

Massachusetts Issues New COVID-19 Guidance and Updates

Massachusetts government agencies have issued recent guidance and updates concerning the COVID-19 emergency. ...more

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