Biologics

IPRP Cell/Gene Therapy Raw Materials Paper

FDA has published an International Pharmaceutical Regulators Program (IPRP) reflection paper, General Considerations for Raw Materials Used in the Manufacture of Human Cell and Gene Therapy Products, to provide the perspectives of the IPRP cell therapy working group and gene therapy working group on the quality of raw materials used in the manufacture of investigational and licensed human cell or gene therapy products. The document says that for purposes of this paper, “raw material” is a general term used to denote reagents, solvents, and excipients intended for use in the production of cell or gene therapy products.

The paper says that raw materials used in the manufacture of human cell or gene therapy products can affect product quality and, consequently, product safety and effectiveness. “Therefore,” it says, “the potential risk introduced by raw materials to cell or gene therapy product quality should be evaluated and managed through adequate processing and testing of the raw materials and appropriate controls and testing in line with good manufacturing practice in the manufacturing of the cell or gene therapy product.”

The paper contains the Position Statement, Background, Risk Assessment for Raw Materials, Production of Raw Materials, General Recommendations, and Examples of Unique Challenges of Commonly Used 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