One of the most stringent rules that must be followed to obtain a patent term extension (PTE) after drug approval is the submission of an application for said PTE within 60 days. As we noted in an earlier post, there have been various instances in …
One year after hosting a public workshop (“Advancing the Development of Interchangeable Products: Identifying Future Needs”), and as part of its BSUFA III commitments, FDA, on September 18, 2026, published for comment a strategy document entitled “BsUFA III Future Needs in the Development of Interchangeable …
What a year for Hatch-Waxman litigation! With the Supreme Court’s decision in Amarin v. Hikma, it’s already been a big year for the Hatch-Waxman Amendments, but now we have another case from the D.C. Circuit that touches on an important aspect of generic drug incentives: …
When perusing regulations.gov, as bloggers searching for content are wont to do, we ran across an interesting Citizen Petition from June that grabbed our attention. Indeed, a June 11, 2026 Petition from Marc R. Matrana, M.D.—System Medical Director of Precision Medicine at the Ochsner MD …
Keeping with the 2026 pace of issuing at least two letters a month, the Office of Prescription Drug Promotion (OPDP) has issued letters 20 and 21 this July, and it’s pretty clear to these bloggers that these summer letters are the “filler” to keep up …
This third installment of our series analyzing the rider provisions in the fiscal year 2026 appropriations legislation continues our examination of key FDA policy directives embedded in congressional committee reports. This post focuses on provisions related to medical devices, pharmacy compounding, GLP-1 medications, and food-areas …
This is the second in our series analyzing the riders attached to the FY 2026 Labor-HHS Appropriations Bill. This installment examines the drug-related provisions, which cover a wide range of topics from accelerated approval and rare disease therapies to biosimilars and opioid regulation. The Committee’s …
On May 1, 2026, the House Committee on Appropriations submitted House Report 119-632 to accompany H.R. 8646—the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2027, which passed on June 4, 2026. The report serves as the Committee’s …
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 …
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 …
While 3-year new clinical investigation exclusivity has never been the holy grail of exclusivities—we reserve that for 7-year orphan drug exclusivity or 5-year new chemical entity exclusivity (with the plus-5-year GAIN and plus-6-month pediatric exclusivity additions!) because of the different lengths and scopes—it plays an …
Are compounders on notice? FDA may be coming for at least one of them, with a little help from its friends at the Justice Department. On the heels of the Novo Nordisk’s Wegovy® pill launch, Hims & Hers, in a headscratcher of a promotional move, doubled …
February is Rare Disease Month, an important time to celebrate successes in addressing the needs of our fellow 25 to 30 million Americans living with a rare disease, but also to renew our resolve in addressing the much larger remaining challenges – both new and …
As some of you know, tucked inside the Consolidated Appropriations Act of 2026, was some legislation that FDA has been pushing for quite some time. In addition to the incredibly important renewal of the Rare Pediatric Disease Priority Review Voucher program (blog on that forthcoming), …
The skinny label has hit the big time. Last week, the Supreme Court agreed to hear Hikma v. Amarin to address the burning question of whether a carve-out induces infringement. As of now, the Federal Circuit has been very clear that a carve-out can induce …
