Drugs

Q&A on Expanded Access to Investigational Drugs

FDA has published a guidance, Expanded Access to Investigational Drugs for Treatment Use, providing information in a question-and-answer format for industry, researchers, doctors, institutional review boards, and patients about the implementation of the agency’s 10/13/2009 regulations on expanded access to investigational drugs for treatment use under an IND. The document adds information on questions FDA has received since the publication of a 2016 guidance that was updated in 2017. The newest questions concern implementation of the regulatory and statutory requirements of expanded access to investigational drugs, including those added by the 21st Century Cures Act and the FDA Reauthorization Act of 2017, the guidance says.

The agency notes there are also separate guidances with answers to questions concerning the implementation of the regulation on charging for investigational drugs under an IND and the process for submitting expanded access requests for individual patient INDs.

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