Drugs

Drug-Drug Interaction Guidances Out

FDA has released two draft guidances that together describe a systematic, risk-based approach to evaluating drug-drug interactions (DDIs) and communicating the results of DDI studies. The first guidance, Clinical Drug Interaction Studies—Study Design, Data Analysis, and Clinical Implications, is to help sponsors of investigational NDAs and applicants of NDAs evaluate drug-drug interactions during drug development and communicate the results and recommendations from DDI studies. It focuses on the conduct of clinical studies to evaluate the DDI potential of an investigational drug, including (1) the timing and design of the clinical studies; (2) the interpretation of the study results; and (3) the options for managing DDI in patients.

The related guidance, In Vitro Drug Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies, focuses on in vitro experimental approaches to evaluate the interaction between investigational drugs that involves metabolizing enzymes and/or transporters. It also discusses how in vitro results can inform future clinical DDI studies. The guidance’s appendices include considerations when choosing in vitro experimental systems, key issues regarding in vitro experimental conditions, and more detailed explanations regarding model-based DDI prediction strategies.

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