Drugs

Post Timely De Novo Summaries: Law Firm

Hyman, Phelps & McNamara senior medical device regulation expert Veronique Li and attorney Jeffrey Gibbs say FDA needs to improve its posting of de novo decision summaries. Writing online in their firm’s FDA Law Blog, Li and Gibbs say that whenever the agency grants a de novo request, it is supposed to issue a decision summary and classification order.

“Sponsors of a new 510(k) device can use the decision summary and classification order affiliated with the de novo to learn about what the de novo applicant submitted and build the case for substantial equivalence to the de novo device,” they write. “In effect, these documents serve as road signs helping to direct new market entrants.”

Although the de novo database is supposed to be updated weekly, Li and Gibbs found that between 2022 and 2024, only 28% had decision summaries posted.

Their review also found that some summaries have been missing for 529 to 822 days and counting. “FDA has not publicly explained why the decision summaries for de novos are not posted in a timely manner,” Li and Gibbs write. “FDA has said that these summaries need to go through multiple levels of review, but that cannot excuse delays or 500 days or more. The agency has done far better in posting 510(k) summaries, which are similar types of documents.”

The post says it is important that the summaries be posted in a timely fashion because delays unnecessarily hamper the ability of other companies to efficiently move through the 510(k) process, which also makes the review process less efficient for FDA.

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