Insights on Life Sciences
411 total results. Page 1 of 17.
Judge Kathryn Kimball Mizelle’s ground-breaking decision in Zafirov v. Florida Medical Associates LLC and Justice Clarence Thomas’ solo dissent in US ex rel. Polansky v. Executive Health Resources Inc. have revived what many had viewed as a settled constitutional question.
On November 21, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments for hospital outpatient services under the Hospital Outpatient Prospective Payment System (HOPPS).
After issuing the Physician Fee Schedule (PFS) on October 31, the Centers for Medicare & Medicaid Services (CMS) has now published templates for manufacturers to utilize when complying with new requirements regarding the submission of reasonable assumptions related to their average sales price (ASP) calculations. CMS also mandates that manufacturers submit Bona Fide Service Fee (BFSF) certification or warranty letters for new or renewal contracts dated January 1, 2026, or later that contain BFSFs with quarterly ASP.
Headlines that Matter for Companies and Executives in Regulated Industries
Now in its 13th year, the Patent Trial and Appeal Board (PTAB) remains a central forum for resolving patent validity disputes.
Headlines that Matter for Companies and Executives in Regulated Industries
Welcome to the November 2025 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.
On October 31, the Centers for Medicare & Medicaid Services (CMS) issued a final rule announcing changes for Medicare payments under the Physician Fee Schedule (PFS), effective on or after January 1, 2026.
The US Food and Drug Administration (FDA) regulates the products hospitals and health systems use, make, or study. As health system innovations increasingly leap quickly across service lines, regulatory obligations can shift in real time.
Headlines that Matter for Companies and Executives in Regulated Industries
Last week’s jury convictions of Safe Chain Solutions’ co-owners in United States v. Brosius, No. 1:24-cr-20255 (S.D. Fla.) coupled with US Food and Drug Administration (FDA) Drug Supply Chain Security Act (DSCSA) enforcement make one conclusion unavoidable: The DSCSA is both a regulatory mandate and a criminal risk boundary.
Headlines that Matter for Companies and Executives in Regulated Industries
Join AFS Life Sciences Partner Stephanie Trunk and Darshan Kulkarni, Life Sciences regulatory and compliance attorney, to unpack the recent acceleration of mergers and acquisitions across the life sciences sector.
Headlines that Matter for Companies and Executives in Regulated Industries
Welcome to the October 2025 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.
Headlines that Matter for Companies and Executives in Regulated Industries
Earlier this month, the US Department of Health and Human Services (HHS) and US Food and Drug Administration (FDA) announced a nationwide crackdown on direct-to-consumer (DTC) drug advertisements.
Headlines that Matter for Companies and Executives in Regulated Industries
On September 12, the US Food and Drug Administration (FDA) released guidance detailing its approach to using alternative tools, such as remote regulatory assessments (RRAs), information sharing with foreign regulators, and virtual inspections, to evaluate drug manufacturing facilities identified in pending marketing applications.
Headlines that Matter for Companies and Executives in Regulated Industries
The Medicaid Drug Rebate Program (MDRP) Summit 2025 will be held in Chicago, IL, from September 15-17, 2025. This hybrid event is hosted by Informa Connect and will feature topics such as 340B, drug pricing policy, and the Inflation Reduction Act (IRA), designed to aid attendees in mastering complex regulatory guidelines.
Welcome to the September 2025 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.
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