Tag: RWE

FDA Virtual Workshop – February 16-17, 2021

FDA Virtual Workshop: Evaluating RWE from Observational Studies in Regulatory Decision-Making  The U.S. Food and Drug Administration and the Duke-Margolis Center for Health Policy will hold a two-day virtual workshop on February 16-17, 2021, focused on considerations about observational (non-interventional) study design and conduct when using evidence from observational studies to inform regulatory decisions.     FDA defines real-world evidence (RWE) as the clinical evidence regarding a medical product’s […]

CDER SBIA Regulatory Education for Industry (REdI) Annual Conference 2020 Recordings

Recordings and slides are available for the 2020 REdI Annual Conference. Day One  Real-world Evidence for Drugs, Biologics, and Devices So, Your NDA Was Approved – Now What?! Post-approval Responsibilities Obligations Restructure of the Office of New Drugs (OND) Overview of Postmarketing Drug Safety Reporting Requirements Enhanced Drug Distribution Security – DSCSA Implementation Updates Drug […]

SAVE THE DATE: 2020 Public Training Courses, Workshops, and Meetings

January 28-30, 2020: ASM Biothreats (Arlington, VA) – Hosted by the American Society for Microbiology, to offer professionals in biodefense, biosecurity, and biological threats the opportunity to exchange knowledge and ideas, and explore the latest developments and emerging technologies. (fee) January 28-29, 2020: HHS Tick-Borne Disease Working Group public meeting (Washington, DC and webcast) – The Working Group will 1) […]

Follow this blog