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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Arnall Golden Gregory LLP

Healthcare Authority Newsletter - September 2024 #1

Arnall Golden Gregory LLP on

News Briefs - HHS Drops Appeal of Court's Ruling in Hospital Web Tracking Case - The Department of Health and Human Services is dropping its appeal of a June U.S. District Court ruling that vacated the government's...more

Womble Bond Dickinson

FDA Rejects MDMA Treatment for PTSD; Setbacks and New Directions

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In a previous blog on the use of psychedelics to treat mental health disorders, we reported that the US Food and Drug Administration (FDA) granted breakthrough therapy designation to MDMA (a.k.a., ecstasy) in 2017 as part of...more

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

Goodwin on

To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

DLA Piper

Food and Beverage News and Trends - September 2024

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. USDA guideline encourages third-party certification of animal-raising and...more

McDermott Will & Emery

Weight Loss Drug Shortages Will End Soon

McDermott Will & Emery on

On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) medications on the FDA’s shortage list. In particular, FDA updated the availability of...more

Knobbe Martens

Science Group Sues FDA Over New Laboratory-Developed Test Rule

Knobbe Martens on

On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024,...more

Goodwin

FDA Approves Moderna’s and Pfizer/BioNTech’s Updated COVID-19 Vaccines

Goodwin on

On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more

Holland & Knight LLP

What's Next for the Regulatory Landscape Post-Chevron?

Holland & Knight LLP on

For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court...more

Goodwin

FTC Comment on FDA Draft Guidance on Interchangeability

Goodwin on

We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

DLA Piper

Food and Beverage News and Trends - August 2024

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. FDA rolls out Phase II of long-term sodium reduction plan. FDA has released new,...more

White & Case LLP

Three Drug Pricing Litigation Issues to Watch in the Second Half of 2024

White & Case LLP on

It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024 #4

McGuireWoods Consulting on

This Week in Washington: HHS announces reorganization of health technology offices; House recesses early because of an inability to pass appropriations bills; Senate Finance Committee chairman introduces legislation to...more

Foley & Lardner LLP

Substance Use Disorder Treatment Services: 2025 Physician Fee Schedule Proposed Rule Would Expand Access and Medicare Coverage

Foley & Lardner LLP on

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule Proposed Rule (Proposed Rule) for the calendar year 2025. The Proposed Rule would implement certain provisions of the...more

Polsinelli

Challenges to LDT Final Rule Continue as Rule Goes into Effect

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As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more

Foley & Lardner LLP

Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans

Foley & Lardner LLP on

On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

Jones Day on

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, July 2024

Bergeson & Campbell, P.C. on

TSCA/FIFRA/TRI - EPA’s Proposed NMP Risk Management Rule Includes Requirements To Protect Workers And Consumers: On June 15, 2024, the U.S. Environmental Protection Agency (EPA) issued a proposed rule under Section 6(a) of...more

Nelson Hardiman, LLP

The Limits of AI in Healthcare: Exploring Ethical and Practical Challenges

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Modern conveniences from washing machines to GPS simplify our lives. In healthcare, however, new technology has not always streamlined delivery. A prime example is the introduction of Electronic Health Records (EHRs) over the...more

Smart & Biggar

2024 mid-year highlights in Canadian life sciences IP and regulatory law

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In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more

Davis Wright Tremaine LLP

Six Key Takeaways on Dietary Supplement Regulation, 30 Years Post-DSHEA

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Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...more

Troutman Pepper

The FDA's Response to AI Medical Innovation — The Good Bot Podcast

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Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Judy O'Grady and Associate...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, June 2024

Bergeson & Campbell, P.C. on

TSCA/FIFRA/TRI - EPA Announces New Resource Portal And Reporting Tool Improvements Before CDR Reporting Begins On June 1, 2024: On May 16, 2024, the U.S. Environmental Protection Agency (EPA) announced the creation of CDR...more

McGuireWoods Consulting

Washington Healthcare Update - June 2024 #2

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This Week in Washington: House Energy and Commerce Committee marks up 13 healthcare bills; House Energy and Commerce Committee Subcommittee on Health holds hearing on CMMI; CMS announces it will recalculate MA Star Ratings....more

Axinn, Veltrop & Harkrider LLP

Hatch-Waxman Overview

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The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy

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Policy differences are endemic in politics, and the phrase "causing more heat than light" regarding federal drug policy comes readily to mind listening to the rhetoric coming from the Federal Trade Commission in this regard. ...more

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