Drugs

Concerns About Drug Shortage Draft Guidance

The Biosimilars Forum says it is concerned that an FDA draft guidance on risk management plans (RMP) to mitigate the potential for drug shortages “is not well tailored to achieving this purpose.” The forum’s 8/4 comment letter says the draft guidance “is not consistent with the law and will impose a heavy burden on industry that will undermine the desired objective of mitigating shortages, and may actually exacerbate them.” The letter says the forum urges FDA to adopt an approach to supply RMPs consistent with the statute and International Conference on Harmonization Q9 principles that affords companies the flexibility to leverage their existing supply chain processes and develop an RMP that best suits individual companies’ business models and needs.

In its comment, Vizient says it appreciates the numerous steps FDA outlines in the draft that may help support quality and redundancy, and encourages the agency to consider opportunities to increase transparency and the production of additional supply.

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