Events

Events March 5, 2019: CDISC SENDIG-AR public webinar, 11:00 a.m. – 12:30 p.m. ET - Free webinar providing an overview of the draft Standard for Exchange Nonclinical Data (SEND) Implementation Guide for Animal Rule studies (SENDIG-AR), hosted by the Clinical Data Interchange Standards Consortium (CDISC). Register by March 5, 2019. See Electronic data standards for Animal Rule studies for more information March 6-7, 2019: Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting (Silver Spring, MD and webcast) - Topics include discussion and recommendations on the selection of strains to be included in the influenza virus vaccines for the 2019 to 2020 influenza season. March 14, 2019: Webinar - The Least Burdensome Provisions: Concept and Principles Final Guidance, 1:00 - 2:30 p.m. ET. This final guidance describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to the regulation of medical devices. New! March 18, 2019: Enhancing the Incorporation of Patient Perspectives in Clinical Trials public workshop (Silver Spring, MD and webcast) - The workshop, convened by the Clinical Trials Transformation Initiative (CTTI), will discuss stakeholders' perspectives on challenges and barriers to patients participating in clinical trials and best practices and key considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, and post-trial follow-up. Register by March 11, 2019. New! March 19, 2019: Webinar - Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices, 3:00 - 4:30 p.m. ET New! March 20-21, 2019: Blood Products Advisory Committee meeting (Silver Spring, MD and webcast) - Matters considered at the meeting will include testing of the blood supply for Zika virus. March 26-29, 2019: Preparedness Summit (St. Louis, MO) - Hosted by NACCHO; FDA is a sponsor. This year’s theme is “Preparedness Summit 2019: The Evolving Threat Environment." (fee)