Drugs

Drug Interaction Study Guide for Contraceptives

FDA has issued a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives. The document is intended to assist sponsors during drug development in evaluating the need for and design of drug-drug interaction (DDI) studies involving combined oral contraceptives (COCs). It discusses when drug developers should conduct DDI studies with COCs and provides recommendations on the design and conduct of DDI studies. The guidance also discusses interpreting and communicating the results and recommendations from these studies.

FDA says the guidance focuses solely on specific recommendations relevant to metabolism-based drug interactions with COCs. Other mechanisms that can cause an interaction (e.g., absorption-based) are not addressed in the guidance but should be considered by sponsors and investigators. In addition, it does not discuss DDIs with progestin-only pills and contraceptives administered via non-oral routes (e.g., transdermal systems). “However, a DDI study with a COC could inform the impact of other types of contraceptives containing the same progestin,” it 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