Drugs

Guide on Tech Specs for NASH Drug Data Sets

FDA has released a final guidance entitled “Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH).” The agency notes that patients with NASH fibrosis have unique clinical considerations (e.g., underlying hepatic dysfunction) that can make it a challenge to show an investigational product’s favorable benefit-risk profile. “Furthermore,” it continues, “evaluation of potential drug-induced liver injury (DILI) in this population is challenging because the risk of DILI in subjects with underlying liver disease has not been fully characterized and it can be difficult to differentiate between the progression of liver disease and DILI.”

The guidance provides detailed information and specifications for the content of tabulated domains and analysis data sets submitted to FDA as part of a sponsor’s application for drugs seeking to treat noncirrhotic NASH. The specifications and information requested are intend to improve a submission’s reviewability, it says. The agency says it does not provide recommendations for clinical development of drugs intended for the treatment of NASH, or assessment of potential DILI.

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