fbpx
February 16, 2024

Data Standards Program Strategic Plan and Board

Strategic Plan CDER’s approach to data standards consists of four strategic goals: Support open, consensus-based data standards development Maintain and promote a well-defined data standards governance […]
February 16, 2024

Newly Added Guidance Documents

Procedural Charging for Investigational Drugs Under an IND: Questions and Answers Final 2/14/2024 Clinical – Medical Use of Data Monitoring Committees in Clinical Trials Draft 2/13/2024 […]
February 15, 2024

Fluorouracil and Pet Safety

[embedded content] Español For many households, pets are our best friends. For some people they are also indispensable service animals. Many show their affection by licking […]
February 15, 2024

Professional Education and Resources

Image Jump to: Project Socrates Project Socrates is OCE’s professional education and engagement effort. In 2023, the project launched a monthly newsletter, the OCE PULSE, for […]
February 15, 2024

Ongoing Clinical Oncology Projects

Image The OCE supports clinical projects to improve oncology product development for the benefit of people with cancer.  Jump to: Patient-Focused Drug Development Program The OCE […]
February 15, 2024

Novel Drug Approvals for 2023

1. Leqembi lecanemab-irmb 1/6/2023 To treat Alzheimer’s diseasePress Release 2. Brenzavvy bexagliflozin 1/20/2023 To improve glycemic control in adults with type 2 diabetes mellitus as an […]
February 15, 2024

Drug Trials Snapshots: BIMZELX

Were there any differences in side effects of the clinical trials among sex, race, and age groups? Adverse reactions through Week 16 of the placebo-controlled trials […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0