Drugs

FDA Launches Expanded Access Navigator Tool

FDA has launched a new tool to help patients seeking expanded access to investigational drugs when there are no alternatives for seriously ill patients. The Expanded Access Navigator is an online tool created under a collaboration including the Reagan-Udall Foundation, pharmaceutical industry, FDA, and others in government. Expanded Access permits a product’s manufacturer, with authorization from FDA, to provide an investigational drug for a patient, even though the drug is still in development or under review. The agency says it receives more than 1,000 applications requesting expanded access annually, according to an online post.

FDA says it has worked to “streamline the process, particularly with a simplified application for individual patient expanded access; however, it can still be challenging and time-consuming for patients, family members, caregivers, and health care professionals to navigate the system.” The tool helps to educate patients and physicians about the process. “Most of what they need to seek expanded access is now available in this single online location, including a directory where companies can submit public links to their expanded access policies, criteria used by companies to determine whether to make a drug available through expanded access, and contact information,” FDA says. “While not a portal for applications, the directory is the first consolidated starting point for researching available investigational therapies. To help users find information quickly, the Navigator is separated into one section for patients and caregivers, and another for physicians.”

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