The Knowledge Shelf

C3TI’s areas of interest span drug development programs, therapeutic areas, and disciplines. Learn more.

She was overwhelmed, but she felt the trial was her best chance for a successful outcome.

Enable and amplify existing and future CDER clinical trial innovation through enhanced communication and collaboration

C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER statisticians, including deepening an understanding of their applicability, opportunities, and challenges.

June 10, 2025, Bornstein Seafoods of Bellingham, Washington is recalling 44,550 Lbs. of Cooked & Peeled Ready-To-Eat Coldwater Shrimp Meat (see table below for multiple lot codes) because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and som

P. East Trading Corp. of Bronx, NY is recalling Salted Smoked Split Herring because the product was found to be over 5″ in length and uneviscerated, as such having potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumer

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions.

Find answers to the most asked questions about medication health fraud and how to identify scams when buying products.

Unapproved New Drugs/Misbranded