Drugs

OCE Soliciting Crowdsourced Research Input

The FDA Oncology Center of Excellence (OCE) has opened a “Send Your Oncology Research Questions to FDA” crowdsourcing challenge to allow interested stakeholders to submit directly to FDA staff their ideas for research using pooled analyses of oncologic clinical trial data. An online notice says agency scientists traditionally have used pooled analyses to deepen understanding of the efficacy of approved drugs, investigate the relationships between different clinical endpoints used in regulatory submissions, and explore the potential for external controls to provide context for single-arm trials.

The notice says OCE now wants to hear the questions stakeholders would like to have addressed with pooled analyses.

After the challenge ends, it says, OCE may select questions for possible future analyses by FDA staff. If a proposed question is selected for further analysis, the submitter will be recognized on the OCE Web site and in social media, invited to a discussion with OCE leadership, and honored at a virtual awards ceremony.

OCE points out that individuals who submit research questions will not obtain access to data or collaborate in any new research studies initiated by FDA.

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