By Mark A. Tobolowsky — On June 2, 2026, FDA (specifically, CBER) issued a new draft guidance...
Category - News
Riders on the Storm Part 2: The Drug Provisions
By Jennifer D. Newberger & Sara W. Koblitz & Deborah L. Livornese & Dara Katcher Levy & Mark A...
Riders on the Storm Part 1: What the FY2027 Appropriations Report Means for FDA
Small Sleep Sacks, Big Compliance Lessons: What FDA’s Happiest Baby Warning Letter Means for Device Manufacturers
Orange You Glad You Used the Right Form?
Coming Soon: Proposed Rule to Remove “Adequate Provision” (and Ban DTC TV Ads?)
ACI’s 13th Annual Summit for Women Leaders in Life Sciences Law
The Battle over Flavor: FDA Wins This Round!
Riders on the Storm Part 3: Devices, Compounding, GLP-1 Medications, and Food