Drugs

Evaluating Gastric pH-Dependent Drug Interaction Guidance

FDA has made available a draft guidance on Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications. The document notes that elevated gastric pH by acid-reducing agents (ARAs) can affect the solubility and dissolution characteristics of ora lly administered drug products. The guidance describes FDA’s recommendations regarding: (1) when clinical drug-drug interaction (DDI) studies with ARAs are needed; (2) the design of clinical DDI studies; (3) how to interpret study results; and (4) communicating findings in drug product labeling. It does not cover other DDI mechanisms for some ARAs such as reduced absorption due to the formation of chelate complexes (e.g., aluminum or magnesium hydroxides, calcium carbonate) for weak-acid drugs and decreased renal elimination of certain drugs as a result of alkalization of urine (e.g., sodium bicarbonate). “When appropriate, sponsors should evaluate the significance of these DDIs during drug development,” the guidance 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