FDA Policy/General

CDER is in Growth Mode from Hiring Spree: Cavazzoni

CDER director Patrizia Cavazzoni says the Center is in “growth mode” after the user fee reauthorization on 9/30/2022, and focused on hiring and staff retention. Speaking at an online Alliance for a Stronger FDA 4/5 update, Cavazzoni said CDER’s staff is over the 5,600 level and there is a “steady growth curve” that has been going upwards month over month in fiscal year 2023. “Our attrition is also down compared to what we saw in the summer of 2021, so on average over the past 12 months it is around 6%, which is good for FDA.

Cavazzoni told the Alliance that the current staff net gain has been further boosted by hiring more staff this year than last year. “So compared to the same time last year, this year we have hired over 270 staff compared to around 140 last year,” she said. “So, this is very good performance and if we look at losses, at this time last year, we had we have lost around 180 staff and this year we have lost only 150… We’re also seeing steady net gains in areas that historically have been very challenging for us, including double digit increases in new medical officers and positions in the quantitative sciences, and so on.”

Turning to real-world data (RWD), Cavazzoni said the agency is disappointed that what it learned during the pandemic is that insurance claims-only environments are not very useful for RWD. Because of this, CDER used some of its pandemic supplemental funding to build out its data environments to include more [electronic health record] EHR data. “And so this is particularly relevant when it comes to one of the PDUFA VII commitments, which is to evaluate how we could use real-world data to a greater extent for pregnancy registries,” she said.

She said that more broadly, CDER really needs to get to a point where it is able to use real-world data to a greater extent for post-market requirements, and “what we’re seeing with claims data is that they’re not fit for purpose… So we think that we need to invest more and hope that we will be able to get more funding to be able to build out our data environments for surveillance, as well as for post-market requirements.”

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

Read more

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