Insights on Life Sciences

ArentFox Schiff is pleased to announce that 68 attorneys were recognized as leaders in their field and 25 practices spanning the firm’s litigation, regulatory, and transactional capabilities, as well as key industries, were ranked among the best in the country in the 2026 edition of Chambers USA: America’s Leading Lawyers for Business.

Headlines that Matter for Companies and Executives in Regulated Industries

ArentFox Schiff’s Gayland Hethcoat on navigating the line between wellness and medical devices in the longevity era.

On April 29, the US Food and Drug Administration (FDA) published a Request for Information (RFI) seeking public comment on a proposed pilot program to test the use of artificial intelligence (AI) in early-stage clinical trials for drugs and biologics. Comments are due June 29.

Headlines that Matter for Companies and Executives in Regulated Industries

ArentFox Schiff is pleased to announce that Partners Craig Gelfound and Ehsun Forghany have been named among Daily Journal’s 2026 Top Intellectual Property Lawyers, an annual list recognizing California-based attorneys whose achievements over the past year have significantly influenced the field.

Headlines that Matter for Companies and Executives in Regulated Industries

On May 1, the US Food and Drug Administration (FDA) announced that it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. If finalized, this proposal would close the last remaining regulatory pathway for large-scale compounding of these popular GLP-1 receptor agonists by 503B outsourcing facilities.

Headlines that Matter for Companies and Executives in Regulated Industries

Headlines that Matter for Companies and Executives in Regulated Industries

Everyone is talking about peptides. Your doctor, your trainer, that guy at the dinner party who swears that BPC-157 rebuilt his knee — peptides have officially entered the zeitgeist. But for every breathless testimonial, there is a thicket of regulations that most market participants barely understand.

On April 18, President Trump signed an executive order (EO) directing multiple federal agencies to accelerate research and expand access to psychedelic drugs as potential treatments for serious mental health conditions. The EO represents a notable shift in federal policy toward psychedelic substances and their potential therapeutic use.

The Federal Trade Commission (FTC) is signaling that health care and life sciences companies should expect heightened regulatory scrutiny related to consumer protection and competition.

Headlines that Matter for Companies and Executives in Regulated Industries

Health care enforcement targeting diagnostic and laboratory services accelerated in 2025 and shows no signs of slowing down in 2026.

Headlines that Matter for Companies and Executives in Regulated Industries

Last month, the US District Court for the District of Columbia struck down a 2013 policy issued by the US Department of Health and Human Services Health Resources and Services Administration (HRSA) regarding the Section 340B Drug Pricing Program “GPO prohibition” and hospital replenishment (virtual inventory) practices.

Headlines that Matter for Companies and Executives in Regulated Industries

While Section 232 tariffs have so far been largely a metals-and-autos story, pharma has now officially joined the narrative.

Headlines that Matter for Companies and Executives in Regulated Industries

Michelle J. Shapiro to speak at Executive Women in Bio (EWIB) virtual program – Implementing Lessons Learned From Enforcement Developments to Improve Corporate Compliance.

Forget science fiction — the race to wire computers directly into the human brain is well underway, and it is moving fast.

Headlines that Matter for Companies and Executives in Regulated Industries

ArentFox Schiff, in collaboration with Consilio, will host the 2026 Chicago Pharma Forum on May 6, 2026, bringing together pharmaceutical industry leaders and in‑house counsel in the Chicago area for a full day of discussion and networking.

Headlines that Matter for Companies and Executives in Regulated Industries