“Whether ‘tis nobler to deviate from the RLD and rely on established data, or take arms against a sea of troubles with a bioequivalent product that conforms to the sameness requirement — that is the question.” That might have been Shakespeare’s opening to Hamlet, had the Bard traded quills for regulatory submissions and Denmark for the District of Delaware or New Jersey.
ArentFox Schiff is pleased to announce that Partner Ehsun Forghany has been named to Benchmark Litigation’s 40 & Under List, recognizing him amongst the “best and brightest litigators across the US.”
ArentFox Schiff is pleased to announce that Managing IP has listed 17 attorneys among the 2026 IPSTARS, recognizing them as leaders in their firm and jurisdiction.
Counsel Judah Prero was quoted on the Minnesota Chamber of Commerce’s request to state regulators to delay reporting requirements for products containing per- and polyfluoroalkyl substances (PFAS).
The Pharmacy Compounding Advisory Committee (PCAC) is a 14-member US Food and Drug Administration (FDA) advisory panel of pharmacists, physicians, and other experts. It reviews the scientific and safety record for bulk drug substances nominated for compounding and votes on non-binding recommendations to the FDA.
Welcome to the July 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.
On July 16, the Centers for Medicare & Medicaid Services (CMS) published the 2027 Physician Fee Schedule (PFS) proposed rule. Among other provisions, CMS has now proposed to convert a previously voluntary filing to a mandatory submission: requiring 340B Covered Entities to submit Part D claims data to the Medicare Part D Claims Data 340B Repository beginning in 2027.
Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules, the Physician Fee Schedule (PFS) proposed rule and the Hospital Outpatient Prospective Payment System (HOPPS) proposed rule, that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year.
On June 2, the US Food and Drug Administration (FDA) released a new draft guidance called “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.”
On June 4, the US Supreme Court issued a unanimous decision authored by Justice Ketanji Brown Jackson in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24–889, delivering a significant win for generic pharmaceutical manufacturers seeking US Food and Drug Administration (FDA) approval for drugs with multiple indications.