Drugs

Comments on Combination Product Draft Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts to clarify through draft guidance the appropriate mechanisms and pathways for combination product sponsors to obtain agency feedback, including the inclusion of best practices regarding interactions between FDA and combination product sponsors. “While PhRMA appreciates the inclusion of these best practices,” a comment letter says, “PhRMA notes that many of these practices are not specific to interactions regarding combination products. PhRMA suggests that FDA reference existing guidance on meetings and interactions between sponsors and FDA, which outline these best practices, thereby allowing FDA to refocus the section on best practices that are unique to interactions regarding combination products.”

In its comment, AdvaMed says the guidance could be improved by additional attention to combination product convenience kits and by mechanisms for non-primary mode of action device makers to receive FDA feedback.

Both stakeholders also offer specific line-by-line comments.

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