Drugs

FDA SSDC White Paper Out

The CDER Center for Clinical Trial Innovation has published a white paper, “Selective Safety Data Collection,” which is defined as the planned reduction in the collection of certain types of data in a clinical investigation for drugs with a well-characterized safety profile. The document describes the FDA 2016 guidance that outlined the agency’s willingness to apply selective safety data collection (SSDC) and the 2022 International Council for Harmonization guidance on the same subject.

“Both documents emphasize the importance of early consultation with regulatory authorities and reaching agreement on a study protocol that will outline how SSDC will be implemented in the clinical trial, and that SSDC does not entail altering local/regional safety reporting requirements or affect the responsibilities of investigators as healthcare professionals to monitor trial participants and ensure that treatment according to prevailing standards of care,” the paper says.

The paper says it covers how SSDC has evolved over the past 10 to 15 years and what FDA hopes to achieve in the coming years with global harmonization of the approach to implementing SSDC in clinical trials designed to evaluate long-term benefits and risks of medical products.

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