INTRODUCTION TO THE FDA 101
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 2017 Patient Advocacy Workshop.
Learn about the numerous ways to get involved as a patient advocate at the FDA, NIH, and ultimately, similar organizations. Understand how to voice your concerns efficiently to create change. Presented by Jack Mitchell at the June 2017 Patient Advocacy Workshop.
Discover the qualities that make a clinical trial a good test of drug and device safety and efficacy. Learn important questions to ask about clinical trial design. Presented by Megan Polanin, PhD at the June 2017 Patient Advocacy Workshop.
FDA Mock Advisory Panel:Belsomra Safety and Efficacy
Review the presentation of data from the clinical trials of Belsomra, a sleep drug, from the Mock FDA Panel activity. Presented by Stephanie Fox-Rawlings, PhD at the June 2017 Patient Advocacy Workshop.
Industry Mock Advisory Panel: Belsomra Safety and Efficacy
Review the Belsomra Industry presentation for a mock-FDA advisory panel. Learn about safety and efficacy concerns regarding a proposed sleep drug. Presented by Diana Zuckerman, PhD; and Jack Mitchell; at the June 2017 Patient Advocacy Workshop.
Learn the importance of studying the safety and effectiveness of drugs/devices on a diverse group of people from different races, sexes, and ages. Presented by Stephanie Fox-Rawlings, PhD at the June 2017 Patient Advocacy Workshop.
