View from Washington

Nov 01, 2018
Applied Clinical Trials
Agency programs aim to increase biomarkers and early advice to sponsors for more efficient and cost-effective clinical trials for rare disease.
Oct 01, 2018
Applied Clinical Trials
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.
Sep 01, 2018
Applied Clinical Trials
Jill Wechsler details new FDA policies to streamline drug development, including the design of “seamless” trials.
Jul 01, 2018
Applied Clinical Trials
FDA is testing various strategies to streamline research and regulatory oversight by looking to novel clinical trial designs to advance new treatments.
Jun 01, 2018
Applied Clinical Trials
Jill Wechsler details the continued rise of incorporating the “patient experience” in drug development measures.
Apr 01, 2018
Applied Clinical Trials
Jill Wechsler on the tug of war in accelerating orphan drug development.
Mar 01, 2018
Applied Clinical Trials
Jill Wechsler details the two chief reasons why clinical trial quality and efficiency has improved in recent years.
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.
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