Drugs

Guide on Bioanalytical Method Validation

FDA has posted a final guidance entitled “M10 Bioanalytical Method Validation and Study Sample Analysis.” The International Council for Harmonization document is intended to provide recommendations for validating bioanalytical methods for chemical and biological drug quantification and their application in the analysis of study samples. “Adherence to the principles presented in this guidance will ensure the quality and consistency of the bioanalytical data in support of the development and market approval of both chemical and biological drugs,” it says. Validating a bioanalytical method demonstrates that it is suitable for its intended purpose. The agency says an alternative approach from the recommendations in the guidance if it satisfies all regulatory and statutory requirements.

The guidance notes that alternative approaches should be supported by appropriate scientific justification. Applicants are encouraged to consult regulatory authorities if making significant changes in method validation approaches.

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