News and Events
News
AUGUST 2019
CDRH Details Top Regulatory Science Priorities
JULY 2019
Sharpless Outlines FDA’s Key Priorities for Advancing Public Health
OCTOBER 2018
FDA Releases Medical Device Guidance for 2019
SEPTEMBER 2018
FDA Announces Compounding Research Projects
SEPTEMBER 2018
Putting the Brake on E-Cigarettes
JULY 2018
FDA Continues Taking Key Actions on Bulk Drug Substances Used for Compounding
APRIL 2018
FDA Goes All Out With Digital Health Regulatory Paradigm Shift
Upcoming Events
FDA-CERSI Collaborative Workshops and Training
A list of upcoming CERSI workshops co-sponsored by FDA and CERSI academic institutions, or held by those individual universities, is on the FDA ORSI website here.
Addressing Challenges in the Design and Analysis of Rare Disease Clinical Trials: Considerations and Tools
FDA Center for Drug Evaluation and Research (CDER) and JH-CERSI Collaborative Workshop
Two-day virtual workshop: May 2, 2023 - 9:00AM - 12:00PM and May 3, 2023 - 9:00AM - 12:00PM
Official Event Page
Event Recording: Day 1 - May 2, 2023 and Day 2 - May 3, 2023
Event Presentation Slides: Day 1 and Day 2
Recent Events
Liquid Biopsies: Transformational Technologies to Enhance Translation from Bench to Bedside and Enable Precision Oncology
FDA CERSI Lecture Series
Valsamo Anagnostou, MD, PhD
Associate Professor of Medical Oncology
Johns Hopkins University School of Medicine
March 7, 2023 - 3:00-4:00PM
Official Event Page
Maximizing Benefits and Minimizing Harms from Antibiotics: Scientific, Regulatory and Clinical Considerations
FDA CERSI Lecture Series
Sara Cosgrove, MD, MS
Professor of Medicine and Epidemiology, Division of Infectious Diseases
Johns Hopkins University School of Medicine
November 8, 2022 - 3:00-4:00PM
Official Event Page
Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation
FDA Office of Women's Health (OWH) and JH-CERSI Collaborative Workshop
May 9, 2022 - 10:00AM - 2:30PM (Virtual)
Official Event Page
IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes
JH-CERSI, M-CERSI and FDA Collaborative Workshop
Virtual
January 26, 2022 - 10:30AM - 3:30PM
Official Event Page
Use of Online Data to Fortify Regulatory Science
FDA CERSI Lecture Series
Mark Dredze, PhD
John C. Malone Associate Professor of Computer Science
Johns Hopkins University
June 9, 2021 - 3:00-4:00PM
Official Event Page
Advancing COVID-19 Regulatory Science Using Clinical Informatics: A Two-Part Webinar
JH-CERSI and FDA Collaborative Webinar
Virtual
May 18, 2021 - 12:00 - 1:30PM
May 25, 2021 - 12:00 - 1:30PM
Official Event Page
For information on future FDA CERSI Lecture Series seminars, please visit the official webpage.