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 […]
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 […]
[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 […]
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 […]
Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) Weight increased FDA is evaluating the need for regulatory action. Braftovi (encorafenib) Tafinlar (dabrafenib) Photosensitivity reaction FDA is evaluating the […]
FDA approves tepotinib for metastatic non-small cell lung cancer On February 15, 2024, the Food and Drug Administration granted traditional approval to tepotinib (Tepmetko, EMD Serono, […]
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 […]
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 […]
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 […]
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