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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

Operation Warp Speed and Vaccine Distribution Policies

Since March 2020, and in some cases before, the U.S. government, Congress and external entities have worked to design plans to reduce the impact of COVID-19 and ultimately prepare for the development and distribution of a...more

Healthcare Policy Update: Election Edition

A presidential race called by media outlets for former Vice President Joe Biden, coupled with a diminished Democratic majority in the U.S. House of Representatives and a narrowly divided Senate, translates into a federal...more

Hemp Industry Brings Case Against DEA to Clarify DEA's Hemp Rule

A hemp trade association and a hemp company have filed a petition in the U.S. Court of Appeals for the District of Columbia Circuit challenging the U.S. Drug Enforcement Administration's (DEA) Interim Final Rule (IFR). The...more

FDA Establishes a New Digital Health Center of Excellence

The U.S. Food and Drug Administration (FDA) has officially launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to expand the agency's activities in furtherance of its...more

USDA Seeks Additional Comments on a Dozen Outstanding Issues Related to Hemp Interim Final Rule

The U.S. Department of Agriculture (USDA) has officially requested additional comments on its Hemp Interim Final Rule (IFR). USDA's request, made on Sept. 8, 2020, follows ongoing industry feedback concerning a list of IFR...more

FinCEN Warns of Scams Relating to PPE and Other Medical Goods During COVID-19 Pandemic

In struggling to address the evolving COVID-19 pandemic, the United States and many other countries continue to face major shortages of Personal Protective Equipment (PPE), such as N95 masks, gowns and other vital materials...more

PREP Act: Liability Protection Is Available During COVID-19 Pandemic

Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more

FDA Updates Policy for Antibody Tests for COVID-19: New Requirements for Manufacturers

In response to the COVID-19 pandemic and the need for more diagnostic testing, the U.S. Food and Drug Administration (FDA) has developed several pathways for manufacturers and developers of COVID-19 diagnostic tests to...more

Legal Insights on the Import of PPE and Other Medical Supplies Vital to Fighting COVID-19

The COVID-19 crisis has revealed the extent to which the United States and other countries are dependent upon a well-functioning global supply chain of critical medical supplies, including ventilators and Personal Protective...more

PPE Shortages: FDA and Chinese Government Issue New Policies for Masks, Gowns and Gloves

The widely reported shortages of Personal Protective Equipment (PPE), including masks and gowns, across the United States have led to the importation, distribution and use of PPE manufactured overseas. In particular, many...more

FDA's COVID-19 Guidance and Policy Update: March 23, 2020

The U.S. Food and Drug Administration (FDA) has issued several final guidance documents to assist manufacturers developing medical products in response to the coronavirus (COVID-19) pandemic. While some are published as...more

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