Drugs

CDER Conversations

CDER Conversations

Talking with Dionne Price, Ph.D., Director, Division of Biometrics IV, Office of Biostatistics, CDER, Office of Translational Sciences/Office of Biostatistics.

Complex innovative trial designs (CID) – including the use of adaptive, Bayesian, and other novel statistical approaches – may help streamline and advance drug development and inform regulatory decision-making. Both the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and the 21st Century Cures Act contain provisions to make the use of CID in drug development and regulatory decision-making easier.

More with Dionne Price, Ph.D.

Resources for You

Page Last Updated: 09/25/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English