Drugs

FDA Expanded Access Web Page Being Improved

FDA says it is updating the agency Expanded Access Web pages to improve usability through streamlining of content and a more user-friendly organization. A statement from FDA commissioner Scott Gottlieb says the updates include a reduction in duplication and the addition of new pages with commonly requested information such as forms and keywords.

The changes are being made in response to comments received from Expanded Access stakeholders who participated in an independent assessment of the program. Gottlieb says the assessment found overall support for the program, and identified steps that could improve it.

In addition to the Web page updates, he said that as part of a reorganization of the Office of the Commissioner, an agency-wide Patient Affairs Staff and Healthcare Provider Affairs Program will be established under the Office of Clinical Policy and Programs. Further, he said, an agency-wide Expanded Access Coordinating Committee has been established to facilitate cross-Center communication and promote discussion to rapidly address cross-cutting issues related to expanded access to promote consistency and best practices.

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