Insights on Life Sciences

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications (NDAs) that relied on bioequivalence studies conducted by Raptim Research Pvt. Ltd, a contract research organization based in Navi Mumbai, India.

Stan Abramson will speak on the Legal Liability Panel at the Biological Products Industry Alliance’s (BPIA) 2025 Annual Meeting in Sacramento, California, on April 2, 2025. His work is focused on chemical, biological, and biotechnology products for agricultural, industrial, and consumer use.

ArentFox Schiff is pleased to announce that the firm and Partner James J. Bindseil have been shortlisted for the annual Managing IP (MIP) Americas Awards.

ArentFox Schiff professionals will discuss recent matters that directly impact the life sciences industry and its trajectory.

Headlines that Matter for Companies and Executives in Regulated Industries

With 2025 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year.

Headlines that Matter for Companies and Executives in Regulated Industries

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics, and medical devices.

Headlines that Matter for Companies and Executives in Regulated Industries

Earlier this month, the US Food and Drug Administration (FDA) issued new draft guidance regarding their accelerated approval pathway for new drugs and biologics, an expedited program designed to help address unmet medical needs for serious or life-threatening conditions. As usual, the FDA is soliciting comments to the new guidance, due by February 4, 2025.

Headlines that Matter for Companies and Executives in Regulated Industries

Headlines that Matter for Companies and Executives in Regulated Industries

This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks.

The United States awoke on November 6 to a changed and improbable political landscape. The nation has re-elected Donald J. Trump as President and has given him a US Senate Republican majority and potentially a US House of Representatives Republican majority as well. As fatigued and steadfast local and state election workers continue to sort through ballots, we continue to look to the finalization of tallies for some remaining Senate and House races to determine the nature and size of Congressional majorities.

Headlines that Matter for Companies and Executives in Regulated Industries

Partner Marylee Jenkins will attend the Brand Strategy Summit USA on October 8, where she will lead an interview titled “Advancing the Trademark System: A Behind-the-Scenes Look.”

Headlines that Matter for Companies and Executives in Regulated Industries

In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing Program, particularly with respect to contract pharmacies.

ArentFox Schiff is pleased to announce that the firm and three partners have been shortlisted for the annual LMG Life Sciences Americas Awards.

Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules.

Welcome to the June 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month.

Join ArentFox Schiff Partners Stephanie Trunk, a recognized authority in government pricing and compliance, and Jacques Smith, a leading health care litigator with extensive experience guiding life science companies through government inquiries, as they share key insights and aim to equip participants with the knowledge to effectively manage due diligence in life science mergers and acquisitions.

ArentFox Schiff is pleased to announce the addition of 17 attorneys and specialists, including eight partners and three counsel, to its Boston office, expanding the firm’s nationally recognized Technology, Life Sciences, Intellectual Property, and Complex Litigation services.

Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR) process under a Final Rule published on April 19, by the US Department of Health and Human Services’ Health Resources and Services Administration (HRSA).