April 15, 2024
Overview The CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program provides the opportunity to test, implement, and scale the integration of innovation into clinical trials […]
April 15, 2024
How will C3TI impact regulatory review? C3TI is likely to have an impact on regulatory review of new drugs in several ways, such as: More efficient […]
April 15, 2024
Selective Safety Data Collection (SSDC) offers an innovative approach to facilitate the conduct of large-scale efficacy and safety trials through the purposeful reduction in the collection […]
April 15, 2024
C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER statisticians, including deepening an understanding of […]
April 15, 2024
C3TI aims to promote the adoption of pragmatic design elements to integrate randomized trials into clinical practice and improve coordination and collaboration between CDER and sponsors […]
April 15, 2024
The Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI) is a central hub that supports innovative approaches to clinical trials that […]
April 15, 2024
TOPLINE: Combined pediatric dermatology-rheumatology clinics can improve patient care and patient satisfaction, a survey of dermatologists suggested. METHODOLOGY: Combined pediatric dermatology-rheumatology clinics can improve patient outcomes […]
April 15, 2024
Who pays the OMUFA facility fee?The facility fee will be assessed for qualifying persons who own an OTC monograph drug facility, including contract manufacturing organization facilities. […]
April 15, 2024
BUDAPEST — Analyzing temporal changes in people’s speech could be a simple way of detecting mild cognitive impairment to see whether there is a risk of […]
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