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HHS Announces Actions to Phase Out Use of Food Additives

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) on April 22, 2025, announced their intent to phase out the use of certain food additives, including petrochemical-based dyes,...more

NIH Announces Significant Changes to Federal Grant Terms, Conditions on Civil Rights

The National Institutes of Health (NIH) announced on April 21, 2025, a significant change to the terms and conditions governing federal funding (the Notice) applicable to all NIH grants, cooperative agreements and other...more

Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More [Video]

In this episode of Holland & Knight's "The Eyes on Washington" podcast series, attorneys Rachel Gartner, Sara Klock, John Vaughan and Michael Werner discuss the evolving landscape of U.S. Food and Drug Administration (FDA)...more

FDA Announces Plan to Phase Out Animal Testing Requirement

The U.S. Food and Drug Administration (FDA) on April 10, 2025, announced a significant policy shift aimed at reducing its reliance on animal testing for drug development and incorporating new approach methodologies (NAMs)...more

Nationwide Preliminary Injunction Halts NIH Indirect Cost Rate Change Notice

Judge Angel Kelley of the U.S. District Court for the District of Massachusetts on March 12, 2025, issued a nationwide preliminary injunction halting the implementation, application or enforcement of the National Institutes...more

HHS Explores Stronger FDA Oversight for Food Ingredients

U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on March 10, 2025, that he directed the acting commissioner of the U.S. Food and Drug Administration (FDA) to explore potential...more

Two Days, Two Hearings: NIH and FDA Nominees Go Before the HELP Committee

Dr. Jayanta (Jay) Bhattacharya, nominated to be Director of the National Institutes of Health (NIH), and Dr. Martin Makary, nominated to be the Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the...more

NIH Cuts Research Funding for Indirect Costs

The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more

RFK Jr.'s 2 Days in the Spotlight: Food Additives, Vaccines and Clinical Trials

Although Robert F. Kennedy Jr.'s nomination hearings to be the Secretary of the U.S. Department of Health and Human Services (HHS) focused on a variety of areas, his testimony and questions from U.S. senators focused on a few...more

Health Dose: Post-Election Edition

Holland & Knight's Healthcare & Life Sciences Policy Team regularly provides updates through our weekly Health Dose. This special Health Dose: Post-Election Edition is intended to outline the short- and long-term potential...more

FDA Rejects Application for Psychedelic Drug

The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos...more

Congress Advances Cannabis and Hemp Proposals

Recent congressional activity highlights the changing environment for cannabis regulation. Specifically, U.S. Congress is moving forward with legislation that will change the regulation of hemp-derived products. The industry...more

Supreme Court Abortion Pill Ruling Doesn't Challenge FDA's Authority

The U.S. Supreme Court on June 13, 2024, unanimously ruled that plaintiffs did not have legal standing to challenge the U.S. Food and Drug Administration's (FDA) actions to establish dosing and availability requirements for...more

Podcast - DEA Plants the Seed for Rescheduling Marijuana: What's Next? [Video]

In this episode of "The Eyes on Washington Podcast," Public Policy & Regulation attorneys Michael Werner, Sara Klock, Joshua Odintz and Ed Perlmutter discuss the proposed rule by the U.S. Drug Enforcement Administration (DEA)...more

U.S. Drug Enforcement Administration Proposes Reclassification of Marijuana

The U.S. Drug Enforcement Administration (DEA) on May 16, 2024, issued a proposed rule to move marijuana from its current classification as a Schedule I drug to a Schedule III drug, thereby loosening federal DEA restrictions....more

Changes in FDA, Cannabis Policies and AI Developments [Video]

In the latest episode of Holland & Knight's Public Policy & Regulation Group "Eyes on Washington" podcast series, Healthcare & Life Sciences attorney Michael Werner and Sara Klock examine pivotal shifts in U.S. Food and Drug...more

FDA Announces Final Regulation Governing Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will be regulated as medical devices....more

Podcast - A Conversation on Cannabis: Are Challenges or Changes Coming? [Audio]

In this episode of the "Eyes on Washington" podcast series by Holland & Knight's Public Policy & Regulation Group, Healthcare and Life Sciences attorneys Michael Werner and Sara Klock discuss recent developments in marijuana,...more

Congressional Leaders Seek Stakeholder Input Regarding CBD Regulation

The bipartisan leadership of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions released a formal Request for Information (RFI) to the public on July 27, 2023, to...more

FDA Issues First Guidance on Clinical Trials for Psychedelic Drugs

The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more

Changes Coming to How FDA Regulates Cosmetics

The FDA announced on Feb. 28, 2023, it will move cosmetics regulation out of the CFSAN and into the OCS. The move stems from the FDA's broader initiative to reorganize food safety regulation and oversight, as well as allow...more

FDA Outlines Post-Pandemic Plan for Medical Devices Now Marketed Under Special COVID Rules

The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special...more

COVID-19 Vaccines: Development, Distribution and Dosing

The Centers for Disease Control and Prevention (CDC) reports that as of Jan. 8, 2021, about 6.7 million people have received at least one dose of a COVID-19 vaccine, far short of the prediction by the Trump Administration of...more

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