Drugs

FDA Expediting Reviews/Approvals to Prevent Shortages After Hurricanes

To prevent drug shortages caused by the hurricanes that hit Puerto Rico last month, FDA has been expediting reviews and approvals of different dosage forms and generic versions of products as alternate sources of critical products coming from the island. In an update on current efforts, commissioner Scott Gottlieb illustrated work between Baxter and the agency to prevent shortages of sodium chloride 0.9% injection bags from its Puerto Rico facility. “Among the FDA’s efforts to assist Baxter, the agency recently helped facilitate the import of these products from the firm’s facilities in Ireland and Australia after the company lost several production days at its Puerto Rico facilities,” he said. “The FDA has also taken many steps to help Baxter restore operations in its Puerto Rico facilities and move critical products onto and off the island.”

Gottlieb said the agency continues to work with other manufacturers to prevent or mitigate shortages. The agency and its government partners are also helping facilities obtain fuel for generators and manufacturing supplies, and with logistical support to move critical products off the island, he said.

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