Avoid Falsely Accusing Female Athletes Who Use Levonorgestrel of Doping

Levonorgestrel, a hormonal contraceptive, metabolises to 18-methyl-19-noretiocholanolone which is also the main metabolite of the prohibited substance 18-methyl-19-nortestosterone. Analysing for…

Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals

This dataset provides a listing of all New Molecular Entities (NMEs) approved from 1985 – 2019 and regulated by the…

FDA Embraces Radical Transparency by Publishing Complete Response Letters

The FDA today published more than 200 decision letters, known as complete response letters (CRLs).

Compounding Quality Center of Excellence | Annual Conference – 08/25/2025

FDA’s Compounding Quality Center of Excellence will host its sixth Annual Conference, August 27 and 28, 2025. Participants can attend…

Laboratory Information Bulletins

Laboratory Information Bulletins available to the public

Bayesian Statistical Analysis (BSA) Demonstration Project

C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER…

Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment

Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment

Compounding Quality Center of Excellence | Annual Conference

Compounding Quality Center of Excellence Virtual Conference

“Do It Yourself” Synthetic Cannabinoid Receptor Agonist Precursors as a Ban‐Evading Strategy: Comparison of the Pharmacological Characteristics of Precursors and Their Final Products

By purchasing “DIY” kits containing ban-evading tail-less SCRAs (such as MDMB-ICA and MDMB-INACA) with weak cannabinoid activity, users are able…

Determining the Compliance of the Sysmex XR‐1000 Haematology Analyser With WADA Athlete Biological Passport Specifications

The athlete biological passport has been established as an anti-doping tool based on the monitoring of biological variables over time.…