Listing patent information in the Orange Book is one of the most important things you can do as an innovator sponsor to ensure that your property rights are respected. And, of course, it’s statutorily required. So that makes the new guidance FDA just issued on …
On June 2, 2026, FDA (specifically, CBER) issued a new draft guidance titled “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing” (the “Draft Guidance”). As suggested by the title, the Draft Guidance is primarily intended for sponsors developing gene …
On June 8, 2026, the Department of Defense published its updated list of “Chinese military companies” under Section 1260H of the National Defense Authorization Act for Fiscal Year 2021. Among the entities newly added: WuXi AppTec Co., Ltd., the China-based contract development and manufacturing organization …
The skinny label is back from the dead. While back in 2021, it seemed like the skinny label was effectively dead after the Federal Circuit twice held Teva liable for induced infringement of GSK’s labeling in GSK v. Teva, the Supreme Court breathed new life …
Don’t look now, but drug repurposing is having a moment. On May 11, 2026, FDA announced a new public docket soliciting stakeholder input on its drug repurposing initiative—specifically, which chronic disease areas should be prioritized and which approved drugs have the most potential to treat conditions …
We have covered a lot of ground on this blog over the years: Hatch-Waxman disputes, REMS programs, and everything in between. Rarely have we had occasion to write a sentence like this one: A podcast host texted the President of the United States about a …
On Tuesday, April 28, FDA issued a press release announcing two major steps it is taking to advance the implementation of real-time clinical trials (“RTCTs”), including two proof-of-concept RTCTs, both in oncology, and a Request for Information (“RFI”) for a proposed pilot program. The goal of …
On March 31, 2026, the FDA published a list of companies that have not submitted required drug amount reports for calendar year 2024. For stakeholders involved in drug manufacturing, this update highlights both a critical regulatory requirement and a compliance gap across the industry. Background: Why …
Last September, we blogged about FDA’s release of Complete Response Letters (“CRLs”) for unapproved NDAs and BLAs, which since then have continued at a steady clip. We observed that the policy marked a significant change from FDA’s longstanding position that such CRLs were exempt from …
FDA has, once again, reminded sponsors that ClinicalTrials.gov results reporting is not optional. In a March 30, 2026 outreach, the Agency contacted more than 2,200 sponsors and investigators associated with over 3,000 clinical trials that appear to be missing required results submissions to ClinicalTrials.gov or have …
As promised and teased in yesterday’s blog post, we discuss other practical implications of and compliance concerns surrounding the ongoing shift in peptide policy below. Supply Chain Complications There is also a supply chain issue that sits upstream of any FDA regulatory authorization of their use in …
The peptide compounding landscape shifted last week, and if you are interested or involved in the peptide industry, compounding pharmacies, telehealth, or the broader market for injectable wellness products, you’ll want to understand what happened—and perhaps more importantly, what hasn’t happened yet. FDA’s PCAC Meeting Announcement We …
The GLP-1 market is set to hit over $30 billion by 2030. Intellectual property litigation and FDA crackdowns have led to a boom in M&A and partnership activity. Long-term patient effects have yet to be fully realized. The future of GLP-1s is bright, but ownership, …
As any well-rounded consumer of television knows, one of the most ubiquitous tropes in sitcoms is the “will they-won’t they” dynamic. Take your pick: Ross and Rachel from Friends, Jim and Pam from The Office, or Mulder and Scully from The X-Files. It’s riveting and …
As many of our blog readers already know, direct-to-consumer (“DTC”) prescription drug promotion has been a regulatory flashpoint for years, and especially recently with FDA’s DTC crackdown (see our previous posts here, here, and here), but a new bipartisan push suggests the conversation may be …
