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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.

Early Vaccine Authorization Raises Ethical & Logistical Challenges for Trial Sponsors

FDA has published updated Emergency Use Authorization (EUA) requirements for new coronovirus preventives.

Industry Backs Clear FDA Standards for COVID Vaccine Authorization

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

COVID-19 Vaccine Concerns Prompt Clinical Trial Transparency

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. 

More Coordination Sought for Exploding COVID-19 R&D Efforts

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

FDA Promotes More Diversity in Clinical Trials

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.

Oncology Therapies Poised for Further Gains at FDA

Gains in FDA approval of new drugs and biologics last year are based on limited clinical trials and accelerated review programs.


FDA Cites Expedited Programs in Boosting Review Process

A view of the notable policy strategies advanced in 2019 to boost drug development and review.   

Novel Strategies Advanced in 2019 to Inform Drug Development and Review

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.




Sponsors Struggle with Trial Disclosure, Patient Privacy Requirements

Regulatory enforcement actions, policy updates, and new guidelines show that ensuring the reliability of clinical data is an ongoing priority.