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Naloxone Access: Answering Questions
Accelerated Approval Program Virtual Public Meeting
The Accelerated Approval Pathway was created by Congress to allow patients with a serious or life-threatening disease earlier access to a potentially important treatment. At this virtual public meeting we explored the insights and lessons learned in the 30 years since its inception.
COVID-19 Evidence Accelerator: Therapeutics/Vaccines Lab Meeting
02/17/2022 - 03:00 PM
During our February Therapeutics/Vaccines Lab Meeting we will hear from colleagues at WHO and Gavi, TriNetX, and Kaiser Permanente California discuss ongoing vaccine research. Nevine Zariffa will also join us to discuss what we see in RCTs vs. RWD studies.
This is our once-monthly COVID-19 Evidence Accelerator Therapeutics/Vaccines Lab Meeting. These meetings occur the third Thursday of every month at 3pm ET.
COVID-19 Evidence Accelerator: Diagnostics Lab Meeting
This is the once-monthly COVID-19 Evidence Accelerator Diagnostics Lab Meeting. These meetings occur the third Thursday of every month at 12 pm ET.
If you are interested in attending the meeting series please email us at evidenceaccelerator@reaganudall.org.
Real-World Data Webinar Series: Considerations for the Use of RWD and RWE
Real-World Data Webinar Series: Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for
Drug and Biological Products
(Guidance for Industry)
Friday, February 11, 2022
11 AM-12 PM Eastern
Real-World Data Webinar Series: Registries
Real-World Data Webinar Series: Assessing Registries to Support Regulatory
Decision-Making for Drug and Biological Products
(Guidance for Industry)
Friday, January 28, 2022
1-2 PM Eastern
Real-World Data Webinar Series: Data Standards
Real-World Data Webinar Series:
Data Standards for Drug and Biological Product Submissions Containing Real-World Data – Draft Guidance for Industry
Friday, December 3, 2021
A Public Webinar Series on FDA-Issued Guidance on Real-World Evidence
A Public Webinar
Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry
November 4, 2021
1:30-2:30 pm ET
COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics
COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics
A Practical Research Agenda for Treatment Development for Stimulant Use Disorder
A virtual public workshop to discuss a practical research agenda toward treatment development for stimulant use disorder.