View from Washington

Articles

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

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.

Data Manipulation Case Spotlights Wider Concerns, Actions

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.

Sponsors, Regulators Cautious About Risk-Based Oversight of Clinical Trials

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.




Too Fast or Too Slow? Debate Intensifies over FDA Regulatory Requirements

Researchers and sponsors are looking to use RWE information to help in trial design, product use, developing new therapies, and gaining market approval.

Real-World Evidence Gains Traction for Informing Clinical Research

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.

More Efficient, Informative Clinical Trials Is the Goal of FDA Leaders

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.


