Insights on Life Sciences

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

Headlines that Matter for Companies and Executives in Regulated Industries

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Earlier this month, the US Food and Drug Administration (FDA) issued new draft guidance regarding their accelerated approval pathway for new drugs and biologics, an expedited program designed to help address unmet medical needs for serious or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

Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance tips. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.

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 CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks.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.

Welcome to the Summer 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance tips.

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).

Janine Carlan will speak at the Fourth Annual Patent Litigation Program IPWatchdog Masters™ series on May 14, 2024.

Welcome to the April 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.

Earlier this month, the US District Court for the District of Oregon issued a declaratory judgment invalidating a key component of the Oregon Drug Price Transparency Program.

As we predicted at the end of the 117th Congress, 2023 was a year of progress for advocates of Pharmacy Benefit Manager (PBM) reform.