Drugs

FDA, Stakeholders Improving Expanded Access: GAO

The Government Accountability Office (GAO) says that FDA and stakeholders, including a non-profit organization and a drug manufacturer, have taken steps to improve the agency’s expanded access process and patient access to drugs. The statement is in a report on GAO’s evaluation of the expanded access program that involved looking at (1) what is known about the number, type, and time frames of expanded access requests received by the agency; (2) what actions FDA and stakeholders have taken to improve expanded access; and (3) how FDA uses data from expanded access in the drug approval process.

As examples of improvements in the process, GAO cites simplification of the FDA Web site, guidance, and the forms required for the most common types of requests. Efforts by stakeholders include a project to educate and streamline the process by which institutional review boards approve treatment plans for expanded access drug use, and a pilot advisory group to help a drug manufacturer manage expanded access requests.

GAO recommended that FDA clearly communicate how it uses adverse events data from expanded access use in the drug approval process, and says the agency agreed with the recommendation.

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