View from Washington

Feb 01, 2018
Applied Clinical Trials
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.
Dec 01, 2017
Applied Clinical Trials
The agency is moving to smooth the pathways for orphan drugs, genetic therapies, and other scientific advances to yield more transformative medicines.
Oct 01, 2017
Applied Clinical Trials
New legislation aims to expand regulatory acceptance of patient data from healthcare systems and observational studies.
Aug 01, 2017
Applied Clinical Trials
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.
Jun 01, 2017
Applied Clinical Trials
With the new FDA commissioner officially in, the FDA begins the considerable task of implementing key "Cures" initiatives.
Apr 01, 2017
Applied Clinical Trials
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.
Feb 01, 2017
Applied Clinical Trials
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.
Dec 01, 2016
Applied Clinical Trials
With a new administration in Washington, sponsors and regulators are weighing several initiatives that promise to reshape clinical research policies.
Oct 01, 2016
Applied Clinical Trials
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.
Aug 01, 2016
Applied Clinical Trials
The need to revise the design, performance and interpretation of clinical research to reflect changing methods and standards is drawing increased attention.
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