FDA Policy/General

Research Groups Urge Improvements to ClinicalTrials.gov

Several clinical research organizations have written the National Institutes of Health and National Library of Medicine urging them to engage FDA and other stakeholders to obtain recommendations for improving ClinicalTrials.gov. Medical product sponsors are required to register their trials and submit results information at ClinicalTrials.gov. According to the letter, the recently enacted 21st Century Cures Act requires enhancements based on stakeholder recommendations to improve usability, functionality, and search capability.

The act directs that the consultation take place not later than 90 days after date of enactment, which would be by 3/12, according the letter. “We appreciate that we are in a period of transition and that the NIH has many new responsibilities placed on it by 21st Century Cures,” it says. “Nevertheless, we are writing to strongly encourage you to adhere to this timeline for the benefit of patients everywhere who are awaiting new treatments and cures.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome