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© 2020 MJH Life Sciences and Applied Clinical Trials Online. All rights reserved.
© 2020 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
October 19, 2020
This week's much-anticipated meeting of FDA’s vaccine advisory committee will address critical issues related to the testing and approval of vaccines to prevent COVID-19 infection.
October 09, 2020
FDA has published updated Emergency Use Authorization (EUA) requirements for new coronovirus preventives.
September 21, 2020
Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.
May 01, 2020
With hundreds of trials for potential coronavirus drugs in the works, concerns swirl around the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.
April 01, 2020
New agency initiatives aim is to fully reflect the impact of treatment on patients representing a range of ages, ethnic backgrounds, and other demographic features
March 01, 2020
The agency's Oncology Center of Excellence continues to build on successes in bringing innovative cancer drugs to patients through accelerated development and speedy approval of breakthrough treatments.
February 01, 2020
Gains in FDA approval of new drugs and biologics last year are based on limited clinical trials and accelerated review programs.
December 01, 2019
A view of the notable policy strategies advanced in 2019 to boost drug development and review.
November 01, 2019
Additional policies for registering clinical studies in U.S. and Europe aim to expand access to research data and provide timely information for patients on promising, new treatments.
October 01, 2019
Regulatory enforcement actions, policy updates, and new guidelines show that ensuring the reliability of clinical data is an ongoing priority.