Drugs

Woodcock: CDER Trying to Fill Translational Science ‘Chasm’

CDER director Janet Woodcock says there is a knowledge chasm in translational science that CDER is helping to fill. Speaking on a Director’s Corner podcast, she says that every disease should have its own translational program and natural history studies that look at disease progression over time. (Woodcock defines translational science as taking discoveries that are made in the laboratory and turning them into products that will help people.)

She says that patient groups are helping to fill in the knowledge gaps by doing natural history studies, pushing researchers to collaborate more, pooling data, having bio banks, and doing other things necessary not just for research but to improve disease outcomes.

For its part, she says, the agency needs to work on better trial designs and incorporating adaptive designs. It also needs to work on patient-focused drug development, she says, and on developing evidentiary standards for biomarkers “so that people know what gate they have to get over.”

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