Drugs

Plan Now to Adopt FDA Trial Diversity Guide: Lawyers

Although FDA says that compliance with its new Diversity Action Plan (DAP) initiative outlined in a recent draft guidance won’t take effect until 180 days after the future final guidance is published, drug and medical device sponsors should start planning how they will comply with the significant new requirements. That’s the advice of five Hogan Lovells attorneys writing in an online post analyzing the draft.

“It is important to note that, when finalized, this guidance will create binding requirements on study sponsors,” the attorneys write. “This is unlike most FDA guidance documents that just provide the agency’s recommendations.”

The post summarizes the draft guidance’s recommendations and requirements on:

which drug and device sponsors should submit DAPs;
the types of content that should be included in a DAP, including the enrollment goals, the rationale for those goals, and the metrics to meet them;
the timeline and procedures for submitting a DAP to FDA;
how diversity goals should be considered when conducting multinational studies; and
the circumstances under which the agency may grant a DAP waiver.

“We recommend that sponsors consider engaging with the agency even before the finalization of the draft guidance to consider which modifications to their clinical development infrastructure will be required to meet DAP requirements,” the attorneys conclude.

FDA will receive comments on the draft until 9/26.

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