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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
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.
September 01, 2019
FDA and other regulators are responding with support for more flexible monitoring of clinical investigators and review of study records in order to limit study monitoring to certain situations.
July 01, 2019
Patient advocates debate whether FDA approval on small, early clinical studies is too fast-tracked for efficacy and safety, or too slow due to long review processes.
June 01, 2019
Researchers and sponsors are looking to use RWE information to help in trial design, product use, developing new therapies, and gaining market approval.
May 01, 2019
FDA leaders urge developers, researchers, and research sponsors to help promote policies and programs to streamline clinical research to develop new medical products at reduced costs.
April 01, 2019
FDA released four new draft guidances that seek to broaden criteria for identifying and enrolling patients in clinical trials in an effort to reduce time and cost of clinical research for biopharmaceuticals.