News & Analysis as of

Food and Drug Administration (FDA) Legislative Agendas

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CMS Releases Final TCET Notice – Implications and Next Steps

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Last week, the Centers for Medicare & Medicaid Services (CMS) issued a final procedural notice for the new Transitional Coverage for Emerging Technologies (TCET) pathway for certain US Food & Drug Administration (FDA)...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Alston & Bird

Look Ahead to the Week of July 22: Congress Returns as 2024 Election Takes Center Stage

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Both the House and Senate are back for two weeks before departing for August recess. Last week, Republicans rallied support for the nomination of former President Donald Trump and his running mate, JD Vance, at the Republican...more

McDermott Will & Emery

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

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The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

Holland & Knight LLP

Holland & Knight Health Dose: May 14, 2024

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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

McDermott+

Healthcare Preview for the Week of: May 13, 2024

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Both chambers of Congress are out of session today and return for the rest of the week. Most healthcare priorities remain out of the congressional spotlight this week, but telehealth is still top of mind. As we...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

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McDermottPlus Check-Up: May 3, 2024

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House Energy & Commerce Health Subcommittee Holds Legislative Hearing on Improving Medicaid Access. Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services (CMCS), testified. Members...more

Bradley Arant Boult Cummings LLP

FDA Chief Says CBD Is Not NBD, Urges Congressional Action

Supporters of hemp-derived cannabidiol (CBD) who hoped the Food and Drug Administration would adopt a more progressive view of CBD were disappointed when FDA Chief Robert Califf recently testified that FDA does not consider...more

Bradley Arant Boult Cummings LLP

Texas Regulators to Consider Changes to Consumable Hemp Program

The Texas Health and Human Services Commission, on behalf of the Texas Department of State Health Services, recently announced that it was accepting public comments to the current rules governing consumer hemp products in the...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: April 2024

Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...more

Bradley Arant Boult Cummings LLP

Legalizing LSD? FDA Says Mm-hmm to MM120

If you know either of us, you know neither of us would pass up a chance to say, “I told you so.” As we looked ahead to 2024 in January, we speculated that psychedelics could be legalized as a prescription medicine. Now, not...more

Alston & Bird

Look Ahead to the Week of March 4: The State of the Union and Government Spending

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Look Ahead to the Week of March 4: The State of the Union and Government Spending - Both the Senate and House are in session. This week, Congress will attempt to pass the first tranche of government spending bills after...more

Perkins Coie

New Pet Food Proposal Introduced in US House

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On February 15, a bipartisan group of five Congressional Representatives introduced the Pet Food Uniform Regulatory Reform Act of 2024 (the PURR Act) in the U.S. House. Currently, the FDA’s regulation of pet foods is...more

Holland & Knight LLP

Holland & Knight Health Dose: February 6, 2024

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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

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Mintz - ML Strategies

ML Strategies Outlook for 2024

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Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more

Holland & Knight LLP

Holland & Knight Health Dose: October 31, 2023

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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

Sheppard Mullin Richter & Hampton LLP

FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”). The...more

Paul Hastings LLP

From General Discretion to Agency Authority? FDA’s Bold Bid to Regulate Laboratory Developed Tests

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After years of FDA discussion and failed congressional efforts to assert greater oversight of laboratory developed tests (LDTs), FDA has proposed a rule that would require many LDTs to comply with FDA’s requirements for in...more

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McDermottPlus Check-Up: October 13, 2023

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CONGRESS - House Republicans Working to Elect New Speaker. On October 11, House Majority Leader Scalise won the Republican Conference’s nomination to become Speaker of the House after last week’s motion to vacate Speaker...more

McDermott+

McDermottPlus Check-Up: October 6, 2023

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THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more

McDermott Will & Emery

Laboratory-Developed Tests: FDA Publishes Highly Anticipated Proposed Rule

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On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more

McDermott+

The Ongoing Poker Game Between Congress and FDA: Who Will Win?

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Congress and federal agencies often engage in a game, each trying to see what the other is willing to do to achieve a particular policy or outcome. While Congress and federal agencies have unique authorities (legislative...more

Bradley Arant Boult Cummings LLP

To Reschedule or To Deschedule: That Is the (Marijuana) Question

Now that the dust is starting to settle on the recent news that the U.S. Department of Health and Human Services (HHS) has recommended to the U.S. Drug Enforcement Agency (DEA) that marijuana be moved from Schedule I to...more

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