Insights on Life Sciences

Health Care Partner Stephanie Trunk will participate in the External Counsel Fireside Chat at Informa Connect’s Pricing & Contracting USA 2025 conference in Philadelphia, Pennsylvania, on May 21.

Headlines that Matter for Companies and Executives in Regulated Industries

There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota.

Headlines that Matter for Companies and Executives in Regulated Industries

The ArentFox Schiff Life Sciences team takes a look at what changes may impact life sciences companies in 2025.

Headlines that Matter for Companies and Executives in Regulated Industries

Headlines that Matter for Companies and Executives in Regulated Industries

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s long-standing interpretation of the Anti-Kickback Statute (AKS).

Headlines that Matter for Companies and Executives in Regulated Industries

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).

Headlines that Matter for Companies and Executives in Regulated Industries

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.

Welcome to the Winter 2025 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.

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

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