Drugs

PhRMA Agrees with Discontinuance Recommendations

Pharmaceutical Research and Manufacturers of America (PhRMA) says it generally agrees with the recommendations in an FDA draft guidance on notification of a permanent discontinuance or interruption in manufacturing under section 506C of the Federal Food, Drug, and Cosmetic Act. In a comment letter, PhRMA says the additional clarity provided on the type of information and process for submitting notifications will help manufacturers as they continue to work with the agency to address potential drug shortages.

The letter notes that section 506C notifications are only one piece of the efforts PhRMA members take to help mitigate or prevent drug shortages. “PhRMA members regularly communicate with FDA, beyond required reports and notifications, to keep the agency abreast of the potential for drug shortages,” the letter says. “This includes voluntary outreach to the agency when there are significant unanticipated spikes in demand that have the potential to lead to drug shortages, consistent with FDA’s recommendations in the draft guidance.”

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