Drugs

FDA Expands Drug Safety Contract with Commonwealth Informatics

FDA and Commonwealth Informatics have signed a new contract to support the use of advanced drug safety review tools at CDER and CBER. Under the new agreement, Commonwealth will support the expanded use of its “analytic suite of tools to help FDA manage their drug and product safety proactively and strategically in drug approval and post market surveillance,” a company release says. “The long-term objective of the project is to build on CDER’s and CBER’s present use of Oracle signal detection software and to expand its usage strategically. The expansion includes providing CDER safety reviewers with the ability to evaluate a wider spectrum of health information sources including spontaneous reports, electronic health records, clinical trials, product labeling, social media, biomedical citations, search logs, and chemical and biologic data.”

The contract also calls for Commonwealth to upgrade FDA to the latest versions of the Empirica Suite tools that it is presently using and provide enhanced support to agency reviewers. “This support includes day-to-day on-site and remote training and assistance for end users, data curation and enhancement of data content and data feeds, support for related and add-on applications, and the provision of Subject Matter Expert (SME) services in the use of the tools,” the company 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

Read more

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