Drugs

Biomarker Bioanalytical Method Validation

FDA has published a guidance, Bioanalytical Method Validation for Biomarkers, to help sponsors of INDs and applicants of NDAs, BLAs, sNDAs, sBLAs, and ANDAs to validate bioanalytical methods used to evaluate biomarker concentrations. The document says it can also inform the development of bioanalytical methods used to analyze biomarker concentrations in nonclinical study samples.

“The recommendations in this guidance pertain only to the validation of bioanalytical assays to measure in vivo biomarker concentrations in biological matrices such as blood or urine,” FDA says. “This guidance does not apply to bioanalytical method validations for the measurement of veterinary drug concentrations or veterinary biomarker concentrations.”

A 5/2018 guidance is being withdrawn with the publication of this document.

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