Division of Clinical Research

Office of the Vice President and Innovation

Category results for: Webinar

FREE Webinar: Regulatory Perspectives for Development of Drugs for Treatment of NASH

The following FDA webinar is FREE and offers SOCRA CE! Regulatory Perspectives for Development of Drugs for Treatment of NASH January 29, 2021 | 1:00 – 2:30 PM Eastern Register here: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-perspectives-development-drugs-treatment-nash-01292021-01292021?utm_medium=email&utm_source=govdelivery FDA will provide a summary of FDA’s current thinking on the published draft guidance documents: Non-cirrhotic Non-alcoholic Steatohepatitis (NASH): Developing Drugs for Treatment, and Non-alcoholic Steatohepatitis […]

Webinar Materials: Final Guidances on Safety and Performance Based Pathway Criteria for Certain Device Types

On September 24, 2020, the U.S. Food and Drug Administration (FDA) hosted a webinar for industry and other stakeholders interested in learning more about two final guidance documents that provide performance criteria for the following device types in support of the Safety and Performance Based Pathway:  Conventional Foley Catheters Cutaneous Electrodes for Recording Purposes  You […]

FDA webinar: CDER’s NextGen Portal

Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead! (for submissions not required in eCTD) This webinar provides an overview of CDER’s NextGen Portal for those in industry who are currently not required to submit in eCTD and are sending information to CDER in paper. CDER’s NextGen Portal is designed to allow a sponsor […]

Webinar on PHUSE/FDA Data Science Innovation Challenge

October 8, 2019 10:00 a.m. – 11:00 am EDT PHUSE invites you to a special webinar announcing the “PHUSE/FDA Data Science Innovation Challenge”. The challenge provides a framework and an opportunity for the greatest minds in the data sciences arena to come together and collaborate intensively on projects during a defined time frame to create […]

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