BASICS OF FDA PROCEDUES & POLICIES
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 October 2016 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 Paul Brown at the October 2016 Patient Advocacy Workshop.
Discover the basics of clinical trial design including the different types of clinical trials. Find out which type is the gold standard for clinical research. Presented by Miara Jeffress, PhD at the October 2016 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 October 2016 Patient Advocacy Workshop.
Review the Belsomra presentation for a mock-FDA advisory panel. Learn about safety and efficacy concerns regarding a proposed sleep drug. Presented by Diana Zuckerman, PhD; and Miara Jeffress, PhD; at the October 2016 Patient Advocacy Workshop.
Subgroup Analysis: What is it? Why Should We Care?
Check out how the method of creating clinical trials can influence a drug's or medical device's approval. Presented by Stephanie Fox-Rawlings, PhD at the October 2016 Patient Advocacy Workshop.
