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© 2021 MJH Life Sciences and Applied Clinical Trials Online. All rights reserved.
© 2021 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
January 19, 2021
The process of distributing millions of doses of new vaccines across the nation has been much less effective than anticipated.
January 14, 2021
Efforts by the Trump administration to limit FDA’s authority have rekindled calls for FDA to become an independent regulatory agency.
January 07, 2021
Applications put on hold as agency limits alternative oversight methods.
CDER's process for vetting and authorizing important new therapies remained strong and productive last year, despite the need to deal with COVID-19 related approvals and policies.
November 12, 2020
President-elect Biden has announced initiatives to combat the widening coronavirus pandemic including a 13-member COVID advisory board.
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