Columns | View from Washington

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

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.

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

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

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.

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

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.

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

A view of the notable policy strategies advanced in 2019 to boost 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.

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

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.

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.

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

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.

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

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 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.

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

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

Now the challenge to FDA and to sponsors is to maintain the high level of support for research, discovery, and regulatory flexibility underpinning these gains, writes Jill Wechsler.

The agency is moving to smooth the pathways for orphan drugs, genetic therapies, and other scientific advances to yield more transformative medicines.

New legislation aims to expand regulatory acceptance of patient data from healthcare systems and observational studies.

The agency is encouraging drug companies to adopt innovative research methods and development tools-and showing more flexibility in approving therapies that have taken non-conventional paths.

With the new FDA commissioner officially in, the FDA begins the considerable task of implementing key "Cures" initiatives.

The rise of new drugs targeting rare disease ignites increased push for flexible R&D approaches and more collaboration on orphan drug designation and clinical trial design between global regulators.

The needed resources to implement "Cures" legislation makes it critical that user fee programs for drugs are reauthorized well before they expire on Sept. 30.

With a new administration in Washington, sponsors and regulators are weighing several initiatives that promise to reshape clinical research policies.

FDA and industry have agreed on a set of recommendations for revising the drug user fee program, which now sits before Congress as U.S. election nears.