April 15, 2024
Seizure burden, defined by an artificial intelligence (AI) algorithm applied to point-of-care electroencephalography (POC EEG) recordings, can help predict functional outcomes. After relevant cofactors were controlled […]
April 15, 2024
Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process […]
April 15, 2024
Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs Recently I had the privilege of official travel to the U.K. and European Union (EU) […]
April 15, 2024
Docket Number: FDA-2019-D-3132 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors of investigational new drug applications […]
April 15, 2024
4/15/2024 FDA establishes CDER Center for Clinical Trial Innovation (C3TI) 3/25/2024 CDER Establishes New Quantitative Medicine Center of Excellence 3/15/2024 FDA Announces New Quality Oversight Webpage […]
April 15, 2024
[4/15/2024] Today, FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to […]
April 15, 2024
CDER Center for Clinical Trial Innovation (C3TI) Content current as of: 04/15/2024 Regulated Product(s) Topic(s)
April 15, 2024
Content and Format of the C3TI Demonstration Program Proposal The C3TI Demonstration Program proposal should include the information below and not exceed 10 pages. The sponsor […]
April 15, 2024
CDER established the CDER Center for Clinical Trial Innovation (C3TI) in April 2024 to enable and amplify innovative approaches to clinical trials that are designed to […]