Biologics

FDA Facilitating Efforts to Coordinate Regenerative Medicine Therapy Standards

FDA says that in response to a section of the 21^st Century Cures Act on developing standards for regenerative medicine therapies, it is facilitating efforts to coordinate such standards development. In an online notice, the agency says it has awarded an annual contract to Nexight Group and the Standards Coordinating Body to coordinate community efforts toward the development of standards for regenerative medicine therapies.

Under the contracts, FDA says, Nexight has used public workshops and Webinars to develop processes that have enabled the identification of needed standards and facilitated the development of standards that have a high impact on the quality and safety of regenerative medicine therapies. Nexight also has published annually “The Regenerative Medicine Standards Landscape,” a report identifying needed standards, standards under development, and existing standards applicable to analytical testing, bioprocessing, product quality, preclinical study standards, and clinical trials of regenerative medicine therapies.

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