Drugs

FDA Gives Octo $300 Million Approval Process Contract

FDA has awarded Octo Consulting a $300 million seven-year contract to meet 21^st Century Cures Act requirements to develop a more efficient and streamlined drug and medical device approval process. A company announcement says Octo was chosen by CDER “to support a comprehensive suite of strategic capabilities and processes, and management of an underlying data analytics technological platform that will streamline and enhance the regulatory, surveillance, compliance, and enforcement oversight of pharmacological and biological therapeutic drugs.”

Octo says it will partner with CDER to enhance and extend the agency’s drug evaluation processes including human drug data submission, management governance and review, full application lifecycle development, operations and maintenance support, and training support. “Octo will maintain and modernize the CDER informatics platform used by the agency to execute the entire lifecycle of the drug approval process,” the consulting firm 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