Drugs

Stakeholder Suggestions for IHC Q5A Guidance

The Biotechnology Innovation Organization (BIO) recommends ways FDA could strengthen its International Council for Harmonization Q5A draft guidance on evaluating the viral safety of biotechnology products derived from cell lines of human or animal origin. The association’s comment letter recommends that FDA:

clarify the role/conduct of new molecular test methods for cell line qualification;
provide further detail/examples on the application of risk assessments for viral contaminants;
ensure examples are clear and consistent; and
clarify opportunities to leverage previous experience/data.

BIO also provides specific line edits.

In its response, Pharmaceutical Research and Manufacturers of America says it generally supports the draft and believes it could benefit from greater clarity on several concepts and that language could be enhanced to better facilitate a shared understanding of the agency’s expectations related to viral safety testing and evaluations. The association also provides 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