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Office of Management and Budget Department of Health and Human Services (HHS) Food and Drug Administration (FDA)

Mintz - Health Care Viewpoints

White House Budget Documents Provide Additional Insights into the Trump Administration’s Priorities for HHS

Over the past few weeks, we have been closely following the Trump administration’s restructuring of the Department of Health and Human Services (HHS), the major reduction in the department’s workforce (RIF), and its broader...more

Alston & Bird

Health Care Week in Review: OMB Issues and Rescinds Memo Freezing Federal Funds; Senate Finance and HELP Committees Hold HHS...

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

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

Holland & Hart LLP

DEA Agrees to Reclassify Cannabis, But Many Questions Remain

Holland & Hart LLP on

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

Mintz - ML Strategies on

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

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

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

McGuireWoods Consulting

Washington Healthcare Update - March 2022 #3

This Week in Washington: President Biden Signs Omnibus Appropriations Package into Law to Fund the Federal Government Through FY 2022...more

MoFo Life Sciences

Biden Administration Executive Order On Promoting Competition In The American Economy: Drug Pricing And Healthcare Industry...

MoFo Life Sciences on

On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more

McGuireWoods Consulting

Washington Healthcare Update - March 2021 #5

Congress - House - Representatives Propose a Permanent Extension of CHIP Funding - The House Energy and Commerce Committee is looking at ways to strengthen the Affordable Care Act (ACA) and expand Medicaid coverage. A...more

McGuireWoods Consulting

Washington Healthcare Update - October 2020 #1

This week in Washington: The Continuing Resolution (CR) to fund the government until Dec. 11 was signed by President Trump; House passes COVID-19 stimulus bill....more

Blank Rome LLP

Executive Order Regarding Domestic Production and Purchase of Essential Medicines: A Lot to Unpack and More Than Meets the Eye

Blank Rome LLP on

On August 6, 2020, President Trump issued another Executive Order (“EO”) that will likely have dramatic and long-lasting effects on the pharmaceutical industry. The impact of the EO may be far greater than currently...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

ArentFox Schiff

White House Issues Executive Order Impacting Drug Supply Chain

ArentFox Schiff on

Members of the industry should be on the lookout for proposed rules related to this Order and take advantage of all public comment periods. The White House issued an executive order “Ensuring Essential Medicines, Medical...more

McGuireWoods Consulting

Washington Healthcare Update - August 2020 #1

This week in Washington: COVID-19 bill negotiations continue. Congress - Hearings/Markups - Senate Committee on Finance: Part 1: Protecting the Reliability of the U.S. Medical Supply Chain During the COVID-19...more

McGuireWoods Consulting

Washington Healthcare Update - July 2020 #3

This week in Washington: House passes first set of Appropriations bills; President Trump signs Executive Orders on Prescription Drugs after COVID-19 bill stalled....more

McGuireWoods Consulting

Washington Healthcare Update - May 2020 #1

This week in Washington: Senate returns to session, Rep. Pallone lays out legislative priorities for COVID-19 response as House delays return to Washington....more

McGuireWoods Consulting

Emerging Technologies Washington Update - April 2020 #4

This week: Coronavirus response, FCC votes in favor of boosting Wi-Fi capacity, Executive Order on immigration rattles tech world....more

McGuireWoods Consulting

Washington Healthcare Update - April 2020 #3

This week in Washington: The House plans to reconvene May 4, Senate Democrats request information from Kushner on health data collection....more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

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