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Food and Drug Administration (FDA) Office of Management and Budget

Perkins Coie

White House OMB Food Industry Updates (Spring 2024 Unified Agenda)

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Pivotal food regulatory updates abound in the recently released Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions, announced earlier this month by the White House Office of Management and Budget (OMB). The...more

Hogan Lovells

OMB releases Spring 2024 Unified Agenda of Regulatory Actions

Hogan Lovells on

The White House Office of Management and Budget (OMB) recently released the Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions, which outlines the rulemaking actions currently under development by each federal...more

Benesch

Pulse on AI + Healthcare: An Introduction to Healthcare AI Innovation in an Evolving Regulatory Landscape

Benesch on

The expansion of artificial intelligence (“AI”) applications in healthcare (“Healthcare AI”) has made recent headlines, from the transformation of clinical diagnostics with increased accuracy, to use of personalized medicine...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - April/May 2024

Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

Sheppard Mullin Richter & Hampton LLP

Bridging the Gap: Cannabis Rescheduling to Align Policy with Research

In a much-anticipated move, sources recently reported that the Drug Enforcement Administration (“DEA”) will recommend rescheduling cannabis from a Schedule I substance to a Schedule III substance under the federal Controlled...more

Tonkon Torp LLP

DEA Reportedly Set to Reschedule Marijuana to Schedule III

Tonkon Torp LLP on

Big news for the cannabis industry: on April 30, 2024, the Drug Enforcement Administration (DEA) announced that it will reschedule marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA). The Biden...more

Holland & Hart LLP

DEA Agrees to Reclassify Cannabis, But Many Questions Remain

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The DEA announced on Tuesday it will accept the Health and Human Services Department’s (HHS) recommendation to reclassify cannabis from Schedule I to Schedule III under the Controlled Substances Act.  This move will have a...more

Amundsen Davis LLC

A Major Step Towards Reform: The DEA Recommends Rescheduling Cannabis

Amundsen Davis LLC on

In a recent historic announcement, the U.S. Drug Enforcement Administration has determined that cannabis, which is currently categorized as a Schedule I drug under the Controlled Substances Act (CSA), should be rescheduled to...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Mintz - ML Strategies

New Biden Executive Order Emphasizes Women’s Health

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Following an initial funding announcement last month, the Biden administration has kept its foot on the gas to build out the White House Initiative on Women’s Health Research. Last month, we wrote about ARPA-H’s $100 million...more

Goodwin

FDA’s Laboratory Developed Test (LDT) Final Rule Under OIRA Review

Goodwin on

On March 1, 2024, the Office of Information and Regulatory Affairs (“OIRA”), Office of Management and Budget (“OMB”), Executive Office of the President received the final version of FDA’s rule on regulation of laboratory...more

Epstein Becker & Green

Making Moves – FDA’s LDT Proposed Rule Sent to OMB for Review

As of Monday March 4, 2024—just three months after the end of its comment period on December 4, 2023—FDA’s rule on regulation of laboratory developed tests (“LDTs”) as medical devices is under review by the Office of...more

Mintz - Health Care Viewpoints

White House Launches Initiative on Women’s Health Research

An important new initiative focused on women’s health research – defined as “the study of health across a woman’s lifespan in order to preserve wellness and to prevent, diagnose, and treat disease” – was recently kicked off...more

Akin Gump Strauss Hauer & Feld LLP

FDA Serves Up More Food for Thought: 2024 Will Be a Pivotal Year for the Agency’s Reorganization Efforts

In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more

Holland & Knight LLP

Holland & Knight Health Dose: December 12, 2023

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Hogan Lovells

OMB releases Fall 2023 Unified Agenda of Regulatory Actions

Hogan Lovells on

The White House Office of Management and Budget (OMB) recently released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions, which outlines the rulemaking actions currently under development by each federal...more

Braumiller Law Group, PLLC

November 2023 Newsletter

In recent years, the global spotlight has illuminated the grave concerns surrounding human rights violations within China's Xinjiang region, particularly those impacting the Uyghur population. The Uyghur Forced Labor...more

Mintz - Health Care Viewpoints

Five Topline Takeaways from FDA’s Proposed Rulemaking on Lab-Developed Tests

It came as a surprise to nobody in health care circles when, on Friday, September 29, 2023, the Food and Drug Administration (FDA) publicly announced that its much-anticipated proposed rule on laboratory developed tests, or...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Regulating AI: An Overview of Federal Efforts

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

Mintz - Health Care Viewpoints

FDA Opens a Pilot Program to Scrutinize Certain Laboratory Developed Tests, But Will It Generate Sufficient Interest?

The U.S. Food and Drug Administration (FDA) announced a new pilot program on June 21, 2023 that gives sponsors of oncology products the opportunity to submit validation and performance data for laboratory developed tests...more

Hogan Lovells

OMB releases Spring 2023 Unified Agenda of Regulatory Actions

Hogan Lovells on

The White House Office of Management and Budget (OMB) recently released the Spring 2023 Unified Agenda of Regulatory and Deregulatory Actions, which outlines the rulemaking actions currently under development by each federal...more

Hogan Lovells

OMB releases Fall 2022 Unified Agenda of Regulatory Actions

Hogan Lovells on

The Office of Management and Budget (OMB) recently released the Fall 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

Polsinelli

Fall Congressional Forecast: Eye on Federal Funding and Health Care

Polsinelli on

Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the...more

Hogan Lovells

OMB releases Spring 2022 Unified Agenda of Regulatory Actions

Hogan Lovells on

The Office of Management and Budget (OMB) recently released the Spring 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

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