Novel Drug Approvals for 2025
Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
Novel Drug Approvals at FDA
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center…
Orange Book Preface
Preface to Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) provides info on how the book came to be,…
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
2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials – 10/11/2023
2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials