FDA Policy/General

precisionFDA Challenge Winners to be Named

Three FDA officials — chief health information officer Taha Kass-Hout, CDRH Office of In Vitro Diagnostics and Radiological Health associate director Zivana Tezak, and precisionFDA project manager Elaine Johanson — say that winners of the first precisionFDA challenge will be announced by commissioner Robert Califf 5/25. The challenge drew 21 entries from 17 submitters.

Writing in an FDA Voice blog post, the three say that precisionFDA is an online, cloud-based, virtual research space the agency created to allow scientists from academia, industry, healthcare organizations, and government to work together on creating tools to evaluate next generation sequencing of DNA. The ultimate goal, they say, is to foster innovation and to develop regulatory science around next generation sequencing tests, which are essential to achieving the promise of the president’s precision medicine initiative.

The community currently has more than 1,500 users from 600 organizations, they say, with more than 10 terabytes of genetic data stored.

Two competitions were set up to engage users and encourage sharing of data and ideas. In the first, whose winners will be announced next week, participants were given two datasets of whole genome sequences from a known human sample, sequenced at two different sites, and were told to use the software of their choice to identify genetic variants and check for consistency between results in the datasets.

The second challenge, which closes 5/26, asked participants to identify genetic variants in one known and one unknown sample dataset. The goal was to see how close they could come to the truth when analyzing data from a human sample with variant results unknown to them.

“The knowledge generation potential for precisionFDA is immense,” the post says, “and leverages the collaboration of the global community to help solve challenges that will ultimately provide insight to regulation to ensure the safety and efficacy of genetic tests. The platform offers users the ability to assemble and run apps, learn from other experts, share lessons learned, participate in competitions, and help to develop standards for assessing the effectiveness of genetic tests.”

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