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 …
In response to what FDA calls “inadequate responses to FDA 483 observations due to a lack or omission of relevant data, excessive amounts of data, and/or failure to address the root cause of observations,” the Agency published a new Draft Guidance on Responding to FDA …
The FDA has issued a notice announcing the opening of a public docket to solicit information and comments on its longstanding Scale-Up and Postapproval Changes (SUPAC) guidances for specific dosage forms. The request signals the Agency’s interest in reassessing these documents in light of evolving …
FDA has published its long awaited Final Rule Revising the National Drug Code Format and Drug Label Barcode Requirements which will expand the dwindling supply of FDA labeler codes and corresponding NDCs to what FDA states is a 900-year supply. As a reminder, NDCs are …
As regulatory frameworks for orphan medicinal products continue to evolve on both sides of the Atlantic, understanding the practical and strategic implications is increasingly important. On March 17th from 10:00 to 11:00 ET, Pinsent Masons and Hyman, Phelps & McNamara, P.C. are pleased to host a …
Two little mice fell in a bucket of cream. The first mouse quickly gave up and drowned. The second mouse, wouldn’t quit. He struggled so hard that eventually he churned that cream into butter and crawled out. Gentlemen, as of this moment, I am that …
