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 […]

On This Page Date: October 16, 2023 Time: 10:00 AM – 4:30 PM ET Workshop Recording [embedded content] About The meeting was held October 16, 2023 […]

For Immediate Release: April 12, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]