The American Conference Institute’s (ACI’s) virtual 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 20-29, 2026 (Eastern Standard Time). Led by an experienced faculty, the virtual training series is specifically designed for attorneys, regulatory affairs professionals, …
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: …
FDA recently released a draft guidance titled Container Closure Systems for Human Drugs and Biological Products. The draft supersedes a 1999 guidance and its 2002 Q&A supplement—documents written before the prevalence of container closure systems (CCSs) like pre-filled syringes, metered dose inhalers, and autoinjectors blurred …
FDA has made no secret of its desire to bring more early-stage clinical development back to the United States. As part of HHS’s Operation TrialBlazer, FDA recently proposed an Expedited Investigational New Drug (“IND”) Pilot Program intended to shorten the path to first-in-human (“FIH”) trials. …
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 …
FDA clinical investigator Warning Letters often involve familiar GCP themes, including protocol deviations, inadequate records, and insufficient oversight. FDA’s recent Warning Letter to a Florida clinical investigator following a Bioresearch Monitoring Program (BIMO) inspection is notable not because it breaks new regulatory ground, but because …
On August 3, 2026, the Health Resources and Services Administration (HRSA) published a Federal Register notice announcing a revised 340B Rebate Model Pilot Program, stating that, for a defined set of drugs, “rebates will be used instead of upfront discounts.” It is HRSA’s second attempt …
The day after CBER’s Cellular, Tissue, and Gene Therapies Advisory Committee meeting on Capricor Inc.’s Deramiocel for the treatment of cardiomyopathy in DMD, the Advisory Committee met on July 30, 2026, to discuss Replimune’s BLA resubmission seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination …
After more than a year with nary an adcomm (just 2 drug approval-related meetings in the Makary era), CBER’s Cellular, Tissue, and Gene Therapies Advisory Committee meetings came back with a vengeance last week with back-to-back meetings to discuss two seemingly controversial cell and gene …
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 …
Well, don’t say we didn’t tell you what was coming. Day 2 of the Pharmacy Compounding Advisory Committee (PCAC or the Panel) Meeting (mostly) followed in the footsteps and at the pace of Day 1 (see our prior coverage of Day 1). Over the course of …
See what we did there? Well, readers, some big things have taken place. “Big things” have happened: we previewed these for you in our two-part FDA’s Pep(tide) Rally! What Compounders and Industry Need to Know blog posts (Part I, Part II). Yesterday, on Day 1 of FDA’s …
Hyman, Phelps & McNamara, P.C. (HPM), the nation’s largest law firm dedicated exclusively to FDA and life sciences law, is pleased to announce that Gayatri Rao, M.D., J.D., M.B.E. has joined the firm as a Director. Dr. Rao brings a rare combination of experience spanning, nearly …
For years, debates over the 340B Drug Pricing Program have played out primarily through litigation, agency guidance, and stakeholder advocacy. Congress, by contrast, has largely remained on the sidelines. That may be changing. Within two weeks, lawmakers in both chambers released significant reform proposals that …
Well, it’s here, it’s happening. The Unified Agenda of Regulations has been updated to include a proposed rule, “Transparency in Direct-to-Consumer Advertising” to remove the (so-called) “adequate provision loophole” from the prescription drug advertising regulations in 21 C.F.R. §202.1(e)(1)(i)(B). The proposal appears to be set …
