Drugs

Transactional Science Role for NIH: Woodcock

CDER director Janet Woodcock says that rather than develop individual products, the National Institutes of Health (NIH) could be of greatest use by filling the gaps in translational science generally to help understand how to evaluate health conditions. Speaking at a 7/25 workshop on the NIH role in drug development innovation and the impact on patient access, Woodcock said NIH has not embraced translational science to help pick drug development winners and lower the failure rate. Such important work is not funded, she said, and is not considered a foundational academic activity.

“Where are the departments of clinical trial design in universities,” she asked. “Where are the biomarker experts?”

She said that translational science has been left to the drug companies and thus has not advanced much because companies don’t share information since they are developing specific products.

“We need to recognize the need and fund it as a critical link in the chain,” she declared. “Filling the gaps in translational science is the only way to lower the cost of product development.”

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