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 […]

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) […]

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 […]

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 […]

[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 […]

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 […]

CDER Center for Clinical Trial Innovation (C3TI) Content current as of: 04/15/2024 Regulated Product(s) Topic(s)

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 […]

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 […]