Drugs

Diversity Plans Needed Before Phase 3: Law Firm

Drug sponsors should consider making race and ethnicity diversity plans an important part of their drug development plans, according to a law firm’s analysis of the agency’s recently published draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” For drug sponsors, FDA recommends submission and discussion of the diversity plan with the agency no later than the End of Phase 2 meetings where sponsors get feedback on their planned pivotal trials, the Hogan Lovells analysis says.

“Sponsors are also expected to submit a formal meeting request to FDA to discuss the plan at the time of submission,” the law firm says. “For devices, sponsors should submit the plan as part of the investigation plan included in the IDE application, or if an IDE submission is not required because the device is non-significant, then the plan may be submitted to FDA in a Q-submission. Notably, the guidance document does not advise sponsors of non-significant risk device studies, who may not otherwise interact with the agency prior to the marketing application, whether it is recommended to present the plan to FDA in a Q-submission prior initiating the trial. Sponsors should also include the plan in the marketing application for the medical product along with a description of the successes and challenges in implementing it.”

Diversity plans should also outline sponsors’ proposed approaches to “collecting data to explore the potential differences in the drug’s safety and effectiveness associated with racial and ethnic backgrounds throughout the product’s life cycle, and plans for pediatric studies that include racial and ethnically diverse populations as part of the medical product development program,” Hogan Lovells says. While the guidance is directed at enrollment of underrepresented ethnic and racial groups, the agency also encourages sponsors to “create plans to ensure adequate enrollment of other relevant and underrepresented populations defined by demographics (e.g., sex, gender identity, disability, pregnancy status),” it 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