Drugs

Race, Ethnicity Data Collection Guidance

FDA has issued a guidance, Collection of Race and Ethnicity Data in Clinical Trials, with the agency’s expectations for and recommendations on using a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated products conducted in the U.S. and abroad. The document says that using standardized terminology for age, sex, gender, race, and ethnicity helps ensure that subpopulation data are collected consistently. The recommended standard is based on an Office of Management and Budget directive and was developed in accordance with several other federal documents, the guidance says.

The guidance says it provides clarifying recommendations on the two-step collection of race and ethnicity data and has been developed in support of the FDASIA 907 action plan to improve the completeness and quality of demographic subgroup data. It replaces a 2005 guidance.

The document says it does not address the level of participation of racial and ethnic groups in clinical trials. Questions about the level of participation should be directed to the appropriate review division.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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