Drugs

Comments on FDA Biomarker Evaluation Draft Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA’s efforts on biomarker qualification, including through the agency’s biomarker qualification program. “The issuance of the draft guidance represents another critical step in qualification of drug development tools by providing a clear and predictable framework for sponsors engaged in biomarker development,” the association says. “PhRMA applauds the incorporation of input from a variety of stakeholder groups across several public workshops, including a white paper authored by FDA, National Institutes of Health, industry, academia, patient groups, and the nonprofit sector describing a framework for defining evidentiary criteria for biomarker qualifications. The comment letter also includes specific recommendations.

The Biotechnology Innovation Organization (BIO) says the draft guidance “outlines a stepwise process to qualify drug development tools for use in drug development. While the process that a sponsor may follow is outlined, we find that the draft guidance should provide information such as timelines that the agency will follow when making determinations whether a submission will be reviewed, when sponsors may expect to receive feedback from the agency, and information regarding how sponsors may interact or engage with the agency regarding their qualification submission.” BIO also includes specific edits it recommends.

In its comment letter, Pfizer gave specific line-by-line recommendations.

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