LINTHICUM HEIGHTS, MD – Sponsors interested in getting their medical device applications approved by the US Food and Drug Administration (FDA) should have robust design controls in place to ensure ...
The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...
We are living in an unprecedented era of rapid medical innovation in the face of COVID-19. The speed of development for devices and diagnostics has been driven by the urgency of the pandemic resulting ...
The FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors can leverage external controls, such ...
Parkinson’s disease (PD) is a neurodegenerative disorder that affects movement, and tremor is one of its signatures. But it is a much more wide-ranging disorder, ...
The U.S. FDA’s final guidance for clinical decision support (CDS) systems may be the subject of two citizen’s petitions requesting the agency scrap the guidance ...
To evaluate the long-term efficacy and tolerability of a representative extended-release (ER)/long-acting (LA) opioid in a 12-month placebo-controlled trial, FDA staff are considering an enriched ...
(I would like to thank Leah Kendall of EpsteinBeckerGreen and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be ...
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