Rethinking Clinical Trials

FEBRUARY 7, 2024

Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA Slides Keywords U.S. Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S.             Speaker Susan C.

Regulation 152

Regulation Production Clinical Trials Clinical Trials 152

Rethinking Clinical Trials

JUNE 29, 2022

Center for Drug Evaluation and Research (CDER). Food and Drug Administration (FDA). With the 21st Century Cures Act of 2016, the FDA established a program to evaluate the potential use of real-world evidence to support new indications for drugs and satisfy post-approval study requirements. Key Points.

Big Data 130

Big Data Clinical Trials Clinical Trials Drugs 130

Rethinking Clinical Trials

JULY 6, 2023

The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. During the COVID-19 pandemic, several regulatory authorities around the world introduced guidance on DCTs.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Rethinking Clinical Trials

AUGUST 28, 2023

 Speakers Prof Sir Martin Landray, FMedSci Professor of Medicine & Epidemiology University of Oxford Chief Executive, Protas Khair ElZarrad, PhD, MPH Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. One important note is that we specifically moved away from a checklist approach.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

AUGUST 28, 2023

 Speakers Prof Sir Martin Landray, FMedSci Professor of Medicine & Epidemiology University of Oxford Chief Executive, Protas Khair ElZarrad, PhD, MPH Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. One important note is that we specifically moved away from a checklist approach.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130