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.
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.
Michelle J. Shapiro to speak at Executive Women in Bio (EWIB) virtual program – Implementing Lessons Learned From Enforcement Developments to Improve Corporate Compliance.
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.
As we continue to move through 2026, the life sciences landscape is shaped by a convergence of regulatory, enforcement, and market access developments that demand heightened attention from industry stakeholders.
Life Sciences Industry Group Co-Leader Stephanie Trunk will present on the evolving reimbursement policy landscape at the Healthcare Distribution Alliance’s (HDA) Distribution Management Conference and Expo on March 9, 2026.
The US Food and Drug Administration (FDA) issued a final rule on March 5 that will change National Drug Codes (NDCs) from several different 10‑digit formats to one standard 12‑digit format.
On February 19, the US Food and Drug Administration (FDA) announced a significant shift in its drug approval framework: A single adequate and well-controlled clinical trial, combined with confirmatory evidence, will now serve as the default standard for marketing authorization of new drugs.
Welcome to the February 2026 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. 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.