We have written on this blog about FDA’s modernization agenda from several angles lately—from the psychedelics Executive Order to the peptide compounding landscape (part 1, part 2)—but here is a storyline that cuts to the operational heart of regulated industry (or at least appears to): FDA …
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 …
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 …
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 …
If you’ve been tracking FDA’s international presence, you know FDA has been through a bit of a roller coaster over the past decade. After consolidating from 13 foreign offices down to 8 between 2012 and 2014—and losing its Pretoria, South Africa office in 2015—the Agency …
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data, excessive amounts of data, and/or failure to address the root cause of observations,” the Agency published a new Draft Guidance on Responding to FDA …
On December 18, 2025, the U.S. Food and Drug Administration (FDA or the Agency) published clarification on its enforcement approach under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) with the release of a draft guidance titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: …
On October 13, 2025, Governor Gavin Newsom signed into law SB 68, titled “Allergen Disclosure for Dining Experiences Act,” officially creating a statewide requirement for certain restaurants to disclose major food allergens on their menus. What SB 68 Requires SB 68: Requires disclosure of the nine major food …
FDA recently released a draft guidance, titled “Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products,” that provides valuable direction and insight into how sponsors can (and should) approach long-term data collection once a cell and gene therapy (CGT) product …
On September 11, 2025, Reps. Diana Harshbarger (R-TN) and Buddy Carter (R-GA)—the only two pharmacists in the U.S. House of Representatives—introduced a new bill, titled “Drug Shortage Compounding Patient Access Act” (H.R. 5316), that would expand the ability of compounding pharmacies and outsourcing facilities to …
There are officially signs of life for FDA’s rare pediatric disease priority review voucher (RPD PRV) program! On September 17, the House Committee on Energy and Commerce marked up the Give Kids a Chance Act of 2025 (H.R. 1262), legislation that would reauthorize FDA’s RPD …
Since 2009, the term ultra-processed food (“UPF”) has gained recognition as there have been studies that suggest a relationship between consumption of UPFs and chronic diseases. The term frequently focuses on processing and composition without consideration of food groups and nutritional composition. At this time, …
On July 14, 2025, the U.S. Food and Drug Administration (FDA) approved Gardenia Blue, a plant-based color additive, while simultaneously making clear to industry that the Agency encourages food manufacturers to accelerate their phasing out of the use of the synthetic dye FD&C Red No. …
