Devices

AdvaMed Seeks Clarification on Ethnicity Data in RWE

The Advanced Medical Technology Association (AdvaMed) says FDA’s draft guidance on “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials” needs to address what sponsors should do in the case of persons who choose not to identify race or ethnicity or those unable to respond to such requests. “Sponsors routinely rely on race and ethnicity designations in electronic health records (EHRs) in real-world evidence (RWE) studies (e.g., prospective registry studies or prospective studies that are supplemented with RWE),” the group says in comments to the agency.

“However,” Advamed continues, “following the guidance, it would appear to suggest that since the patient was unable to respond, race and ethnicity information should not be accessed from the EHR. We recommend that the guidance clearly state that it is applicable to RWE studies and that race and ethnicity information from the EHR may be utilized.”

AdvaMed says RWE can help demonstrate that underrepresented racial, ethnic, or sex groups benefit from a device or alternatively that a product is not performing well in certain populations. “Race and ethnicity data from the EHR is important information in the context of postmarket RWE,” it says. “It is equally important in the context of RWE premarket data. Failure to allow use of race and ethnicity information in the EHR in the premarket setting will create significant incongruities between the use of RWE in the premarket and postmarket settings.”

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