Study Data Standards Resources
Study Data Standards Resources
LC‐IRMS: Towards a High‐Throughput IRMS Methodology?
Recently, an LC-IRMS methodology has become available for analyzing endogenous anabolic steroids in a urinary matrix. This could potentially open…
Hair EtG Testing in Combination With Measurements of PEth and EtG in Blood to Improve the Assessment of Alcohol Consumption
When combining the results of H-EtG with concurrent blood testing of PEth and B-EtG, the assessment of the overall drinking…
Identification of Three Novel Tetrahydrocannabinol Analogs in the European Market
The major isolated ingredient of “CB9” was identified as [2-(E)-propen-1-yl]-Δ8-tetrahydrocannabinol-acetate of “tresconol” as [2-propen-2-yl]-Δ9-tetrahydrocannabinol and of “CBx” as [2-propen-2-yl]-Δ8-tetrahydrocannabinol. These…
Impact of Menstrual Cycle and Oral Contraceptives on Haematological and Inflammatory Biomarkers in Highly Trained Female Athletes
In highly trained female athletes, haematological and inflammatory biomarkers were found to be independent of menstrual cycle phase, but oral…
Hurricane Helene: Baxter’s manufacturing recovery in North Carolina
Information and updates on CDER-regulated drug and biologic products
Jobs in Oncology/Hematology
FDA’s Office of Hematology Oncology Products is recruiting Medical Oncologists to serve in the dynamic, highly challenging, and innovative atmosphere…
Drug Trials Snapshots
Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort…
Institutional Review Boards Frequently Asked Questions
IRB Information Sheet – Frequently Asked Questions
Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products
Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products