FDA DRUG DEVELOPMENT & APPROVAL PROCESS
In greater depth, learn the basics of Food and Drug Administration procedures and policies regarding the drug development and approval process. Presented by Diana Zuckerman, PhD at the June 2016 Advanced Patient Advocacy Workshop.
Refresh your memory of the qualities that make a clinical trial a good test of drug or device safety and efficacy. Learn the statistical tools used in these studies. Presented by Margaret Dayhoff-Brannigan, PhD at the June 2016 Advanced Patient Advocacy Workshop.
Rediscover the importance of studying the efficacy and safety of drugs and devices on a diverse group of people and analyzing their impact on people of different races, sexes, and ages. Presented by Miara Jeffress, PhD at the June 2016 Advanced Patient Advocacy Workshop.
Watch the presentation of data from the clinical trials of Belsomra, a sleep drug, from the Mock FDA Panel activity. Presented by Laura Gottschalk, PhD at the June 2016 Advanced Patient Advocacy Workshop.
Watch the representative from Belsomra's presentation for a mock-FDA advisory panel. Learn about safety and efficacy concerns regarding a proposed sleep drug. Presented by Tracy Rupp, PhD at the June 2016 Advanced Patient Advocacy Workshop.
Discover the facts and myths about participation in a clinical trial for a new drug. Learn important questions to ask a healthcare provider before enrollment. Presented by Tracy Rupp, PhD at the June 2016 Advanced Patient Advocacy Workshop.
