Drugs

FDA in Pistoia Alliance Working Group

Liaisons from CDER will be part of a new In Vitro Pharmacology Working Group being assembled by Pistoia Alliance, a global not-for-profit that says it advocates for greater collaboration in life sciences research and development. The alliance says the working group also will have representatives from biopharmaceutical companies, contract research organizations, technology suppliers, and other regulatory agencies.

“The mission of the group is to improve the data structure and standards for in vitro pharmacology (IVP) data in regulatory submissions, to enable faster reviews and interpretations of submissions, and ensure new therapies reach patients as quickly as possible,” the alliance says.

The working group will create a shared data structure to ensure data consistency in IVP screening across all stakeholders. “The current lack of consistent standards around data input, reporting, and submission is a common challenge that causes significant inconsistencies in regulatory submissions and limits the accessibility and interoperability of the data,” Pistoia says.

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