Drugs

Revised Expanded Access Q&A Guidance

FDA has issued a revised draft guidance, Expanded Access to Investigational Drugs for Treatment Use Questions and Answers, with updated information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of the agency’s regulations on expanded access to investigational drugs for treatment use under an IND. The document, in question-and-answer format, updates a 6/2016 guidance that was previously updated in 10/2017.

FDA says that since 2017 it has received additional questions concerning the 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 (FDARA) of 2017.

“Significant changes from the 2017 version include additional recommendations related to IRB review, informed consent, and new requirements established by the Cures Act and FDARA related to sponsors making their policies for evaluating and responding to expanded access requests public and readily available,” the draft says.

FDA says separate guidances answer questions concerning the implementation of the regulation on charging for investigational drugs under an IND and the use of form FDA-3926 in submitting expanded access requests for individual patient INDs.

When finalized, this draft will replace the 2017 version, FDA says.

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