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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.

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.




FDA Seeks to Broaden Clinical Trial Eligibility Criteria

FDA officials provide more specific plans for streamlining and modernizing plans for assessing and regulating products for cutting-edge cellular and gene-based medical treatments.


FDA Clarifies Research Policies on Cell and Gene Therapies

New FDA guidances outlining recommended approaches for clinical testing methods and collecting research data, alongside with public workshops and meetings, accelerate reviews to speed new therapies to market.



FDA Clarifies Research Policies to Facilitate New Drug Development

FDA is joining with other federal health agencies and the biomedical community to advance science, regulatory policies, and reimbursement strategies to combat the need for new medicines for infectious diseases.

FDA Supports Streamlined Trials for New Antimicrobials

Jill Wechsler details the continued rise of incorporating the “patient experience” in drug development measures.  

Patient Experience Moves to Center Stage in Medical Product Development

Jill Wechsler details the two chief reasons why clinical trial quality and efficiency has improved in recent years.