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Healthcare › Life Sciences › Public Health

Troutman Pepper

New FDA Guidance on AI and Medical Products

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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

Jones Day

Vital Signs: Digital Health Law Update | Fall 2023

Jones Day on

We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, our lawyers describe the increasingly common regulation of...more

Knobbe Martens

FDA Updates Medical Device Shortages List

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The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more

Schwabe, Williamson & Wyatt PC

Washington Psilocybin Law Faces Delay

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People hoping Washington would closely follow Oregon into the regulated use of psilocybin overseen by licensed practitioners faced a delay when a committee of the Washington legislature converted Senate Bill 5263 from...more

Knobbe Martens

WTO Agrees to Partial Patent Waiver for COVID-19 Vaccines

Knobbe Martens on

On June 16, 2022, the World Trade Organization (WTO) agreed to a partial waiver of intellectual property rights related to COVID-19 vaccines. The agreement came on the heels of an all-night negotiating session. The agreement...more

Knobbe Martens

U.S. FDA Approves Monkeypox Treatment Formulation

Knobbe Martens on

(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of...more

Arnall Golden Gregory LLP

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

Arnall Golden Gregory LLP on

Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

Robinson+Cole Health Law Diagnosis on

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

Foley Hoag LLP

Caught in FDA’s Crosshairs: Delta-8 THC Products Invite Increased Scrutiny

Foley Hoag LLP on

The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more

WilmerHale

The Potential Impacts of the Nagoya Protocol on Global Public Health Research

WilmerHale on

The State Department is initiating a public process to consider the implications of Access and Benefit-Sharing (ABS) regimes for global health and biomedical research. The Federal Register Notice announcing this initiative...more

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