Drugs

FDA Triaging Backlog; Prepares for Flood of Submissions

A “welcome back” email from CDER director Janet Woodcock to Center employees returning to work from the just-ended partial government shutdown instructs employees to “pick up the pieces and prioritize the work that has piled up. We can expect other parts of the agency and government to be doing the same, so please be patient if rules, guidances, and so forth are slowed, as well as administrative actions.”

Woodcock also warned employees to not give out estimates to stakeholders about any delays to pending work and submissions. “Every firm with an issue pending before us will be asking for a timeframe, and the trade press and others will be asking for estimates,” she said. “We always try to be helpful to outside stakeholders, but in this case, we need to make collective decisions so please do not give out estimates. Over the next few days, as we sort through what is pending, we will make plans and disseminate them, so we will all be working from the same playbook.”

Meanwhile, a series of tweets from FDA commissioner Scott Gottlieb promises an update soon on application backlogs related to the shutdown and the “efficient process we’ll use to work through these priorities.” According to Gottlieb, the agency typically receives around 400 generic ANDAs in December and January. He said that normally FDA receives about 300 510(k)s and a dozen novel NDAs in January. “Most sponsors were holding their applications during the shutdown, so those applications will all come in now,” he predicted. “Sponsors knew we couldn’t take new submissions, so few tried to submit applications during the funding lapse.”

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