Drugs

ICH/EMA Viral Safety Guide Approved

The International Council for Harmonization (ICH) says the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted 12/14/2023 the ICH

Q5A(R2) Guideline on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin to take effect 6/14. An ICH notice says the guideline 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 those products.

It covers products such as cytokines, monoclonal antibodies, and subunit vaccines produced from in vitro cell culture using recombinant DNA technologies, the notice says. It also covers certain genetically engineered viral vectors and viral vector-derived products (e.g., viral vaccines and gene therapy products), provided they are amenable to viral clearance, without a negative effect on the product. And it covers viral vector-derived products, for example, baculovirus-expressed virus-like particles, protein subunits, and nanoparticle-based protein vaccines and therapeutics.

Inactivated viral vaccines and live attenuated viral vaccines containing self-replicating agents are excluded from the scope of this guideline, the notice says, as are cell therapies, although the principles may be used as applicable (e.g., for biological starting or raw materials).

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