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 Center for Biologics Evaluation and Research (CBER) Real World Evidence Program
Johns Hopkins Student ISPE Lecture
Hui-Lee Wong, PhD
CBER Sentinel Central Team, FDA CBER
January 30, 2020- 12:15 - 1:30PM
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.
Recent Events
The Role of Ontology and Controlled Terminology in Precision Medicine: Implications for Post-Market Surveillance
FDA CERSI Lecture Series
Christopher Chute, PhD
Deputy Director, Institute for Clinical and Translational Research
Johns Hopkins University, Johns Hopkins School of Medicine
November 6, 2019 - 3:00-4:00PM
Official Event Page
Targeting Tumor Specific Receptors for Cancer Therapy by Cancer Vaccines and Cellular Immunotherapy
Johns Hopkins Radiology In Vivo Cellular and Molecular Imaging Seminar Series
Raj K. Puri, MD, PhD
Director, Divison of Cellular & Gene Therapies, FDA CBER
March 20, 2019 - 3:30 - 4:30PM
Assessing and Communicating Heterogeneity of Treatment Effects for Patient Subpopulations: Challenges and Opportunities
JH-CERSI and FDA Collaborative Symposium
FDA White Oak Campus
November 28, 2018 - 8:15AM - 4:30PM
Official Event Page
For information on future FDA CERSI Lecture Series seminars, please visit the official webpage.