Drugs

Woodcock’s Ideas to Strengthen Clinical Trials

FDA acting commissioner Janet Woodcock says the Covid-19 pandemic has revealed issues with the clinical trial system in the U.S. that need to be addressed. In an interview with Outsourcing Pharma, she says there are gaps in the clinical trial infrastructure that could be overcome by creating a national stockpile of connected clinical trial infrastructure and resources.

Such a stockpile, she says, would shore gaps in the nation’s clinical trial system by fixing the current disconnect between the trial and hospital system and building a stronger connection between the two.

She noted that while the country’s healthcare system and institutions had scores of Covid-19 patients in their care, they lacked the resources needed to successfully conduct clinical trials.

She also sees a need for the U.S. to be better prepared to respond when the next pandemic hits. “You can’t build in time when a crisis is upon you,” she says.

In addition to creating a clinical research framework better prepared for the next crisis, Woodcock suggests forging a stronger connection with local care providers and promoting clinical care as a research option, as a means of improving clinical trial participation rates.

“It takes time,” Woodcock concludes. “That’s what we mean by stockpile, you have to have that capacity and readiness, otherwise it’ll take you years to build up that capacity.”

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