Sarfez Pharmaceuticals, Inc. – 708901 – 04/25/2025

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

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.

The FDA is committed to ensuring data transparency by promoting timely registration and reporting of results information to ClinicalTrials.gov.

Unapproved New Drugs/Misbranded

The Food and Drug Administration is advising consumers not to purchase or use PeakMax, a product promoted and sold for sexual enhancement on various websites, including www.vitalityvita.com, and possibly in some retail stores.

Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products.