Drugs

FDA Releases ‘Streamlined’ Expanded Access Application

In an effort to streamline the process doctors use to request expanded access (compassionate use) to investigational drugs and biologics for specific patients, FDA has released a new, much shorter Individual Patient Expanded Access Investigational New Drug Application, that the agency says should only take doctors 45 minutes to complete. In a statement, FDA commissioner Robert Califf says that as a doctor, he understands the importance of being able to access investigational treatments for patients when there are no other options to treat their serious disease or condition.

“Access to investigational treatments requires the active cooperation of FDA, industry, and healthcare professionals in order to be successful,” he says. “But we know that navigating that process can be challenging and time consuming, and we are committed to reducing the procedural burdens on physicians and patients whenever possible.”

Califf says the new application (FDA-3926) can be used to request expanded access to investigational drugs for individual patients who suffer from serious or immediately life-threatening diseases and for whom no comparable or satisfactory alternative therapy is available. The agency also is releasing step-by-step instructions for completing the form.

Also released are two additional final guidances. The first is in a question-and-answer format to explain what expanded access is, when and how to request expanded access, and the type of information to be included in requests. The second explains the regulations covering how patients may be charged for investigational drugs.

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