Drugs

ICH Viral Safety Evaluation Guidance

FDA has published the International Council for Harmonization’s Q5A(R2) guidance, Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. The document describes the evaluation of the viral safety of biotechnology products including viral clearance and testing, and outlines what data should be submitted in marketing applications for the products.

The guidance includes products such as cytokines, monoclonal antibodies, and subunit vaccines produced from in vitro cell culture using recombinant DNA technologies. It also includes certain genetically engineered viral vectors and viral vector-derived products, provided they are amenable to viral clearance without a negative effect on the product.

The guidance includes an Introduction; Potential Sources of Virus Contamination; Cell Line Qualification: Testing for Viruses; Testing for Viruses in Unprocessed Bulk; Rationale and Action Plan for Viral Clearance Studies and Virus Tests on Purified Bulk; Evaluation and Characterization of Viral Clearance Procedures; Points to Consider; Summary; Glossary; References; Tables; and Appendices.

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