Drugs

FDA Launching Patient Guidance Snapshots

The FDA Guidance Snapshot Pilot Program, a joint effort of the CDER Office of Translational Sciences (OTS) and the CDER Office of Communications (OCOMM), will soon expand with the issuance of its first two snapshots and podcasts for patients. The program is explained in an online post featuring interviews with OTS director ShaAvhrée Buckman-Garner and OCOMM director James-Denton Wyllie.

Buckman-Garner says the pilot uses both guidance snapshots and a guidance recap podcast. The guidance snapshot, she says, are visual documents that convey key recommendations from guidances using plain language and graphics. They offer a condensed look at what each guidance recommends, why the guidance is important, background information on the guidance topic, when to apply the guidance recommendations during the development process, and where to submit official comments on draft guidances.

The podcasts provide highlights and background information on guidances through conversations with the authors.

Wyllie says it is essential that information in guidances is accessible to multiple audiences, rather than only to drug developers. “The translational science that fosters drug development occurs from bench-to-bedside and involves different stakeholders participating in every step along the development process, including research scientists, academics, policymakers, patients, advocacy groups, and healthcare professionals,” he says.

Buckman-Garner says the pilot is continuing to update its snapshots and podcasts and is ready to expand to the patient community, with the first two snapshots intended for patients launching soon.

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