Drugs

PhRMA Seeks More FDA Info on Rare Disease Steps

Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA virtual meeting on advancing the development of therapeutics through rare disease patient community engagement “provided a critical forum to discuss best practices and opportunities for engaging with rare disease patients and other key stakeholders throughout the rare disease drug development process.” The association’s comment letter says PhRMA encourages FDA to provide information about how the agency leverages patient experience data (PED) in regulatory decision-making.

“We request that the agency provide additional details regarding how PED,” it says, “including but not limited to clinical outcome assessments used in clinical trials and patient preference information collected within or outside clinical trials, is used in the context of benefit-risk decisions and overall totality of evidence regarding patient experience in drug development.”

The trade group also wants FDA to clarify how PED may be incorporated into product labeling and the agency’s expectations for PED-related discussions with industry during product development.

The letter also includes specific 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