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The process of distributing millions of doses of new vaccines across the nation has been much less effective than anticipated.

Vaccine Rollout Worse than Expected, Mars Research and Regulatory Successes

Efforts by the Trump administration to limit FDA’s authority have rekindled calls for FDA to become an independent regulatory agency.

FDA Struggles to Fend Off Further Attacks from Trump Administration

Applications put on hold as agency limits alternative oversight methods.

FDA Inspection Shutdown Increasingly Delays Approvals

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.

Despite Pandemic, FDA Ramps Up New Drug Approvals

President-elect Biden has announced initiatives to combat the widening coronavirus pandemic including a 13-member COVID advisory board.

Tackling COVID Top Priority for New Administration

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