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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
Annual facility fees and Generic Drug Applicant Fees are due October 1st of each applicable FY. Content current as of: 04/12/2024 Regulated Product(s) Topic(s)
Generic Drug Facilities, Sites and Organization Lists | FDA In this section: Generic Drug User Fee Amendments Home For Industry FDA User Fee Programs Generic Drug […]
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