Drugs

FDA Mulls New Drug Shortage Authority: Woodcock

CDER director Janet Woodcock says FDA is considering whether there is more it can do under the FDA Safety and Innovation Act to better address drug shortages. Speaking in a Center podcast, Woodcock says they are researching whether they have the ability to require applicants of certain drugs to identify any risks or vulnerabilities in their drug supply chain and develop risk management plans to have in place in advance in case something happens.

“With these contingency plans in place,” she says, “shortages can be more easily managed and resolved, doing this work up front rather than when you’re facing a crisis. We also have been encouraging the adoption of new technology, such as continuous manufacturing, that reduces supply disruptions. Our engineering technology program team works with drug makers to develop and implement these new technologies. But we can’t require that manufacturers increase production of a drug in shortage, and we don’t have control over business decisions that affect the supply chain. But we can all work together to minimize disruptions and lessen the impact of drug shortages on our patients.”

In the podcast, Woodcock also discusses some of the notable recent shortages and the typical causes of drug shortages, along with steps the agency is taking to address the issue and ideas of what industry can do.

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