Drugs

3 Stakeholder Comments on FDA QTc Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that an FDA draft guidance on QTc information in drug and biological product labeling does not fully embrace approaches discussed in a related International Council on Harmonization guideline. “We have concerns that the draft guidance effectively discourages the use of an integrated risk assessment as a substitute for a clinical Thorough QT study to demonstrate low risk for clinically relevant QT prolongation,” the PhRMA comment letter says….“Internationally harmonized guidance is particularly important because it helps ensure alignment among ICH member regions, preserves efficiency in pharmaceutical research, development, and manufacturing, and facilitates patient access to medicines more efficiently. We encourage FDA to revise the draft guidance to facilitate an internationally harmonized approach to the adoption of the [ICH guidelines] and application of the integrated risk assessment.”

PhRMA also provides specific line-by-line comments as do Boehringer Ingelheim and Jazz Pharmaceuticals.

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