FDA Policy/General

FDA Report Outlines Workforce Needs

A new FDA report outlines the agency’s current workforce needs as mandated by the 21st Century Cures Act. New authority in the Act “provides tools to efficiently recruit and retain scientific, technical, and professional staff needed to continue advancing innovation and fulfilling FDA’ s mission,” the report says. The agency can now bring professionals on board and pay them up to $400,000 annually. “FDA can develop its own Alternative Pay System (APS), giving the agency enhanced flexibility (and guidelines) to offer salaries for highly skilled professionals that are closer to, and more competitive with, market salaries,” the report says.

Cures also provided the flexibility to speed time to hire, according to the report. FDA is now using “corporate recruiting” to fill multiple vacancies for the same job series across Centers by posting a single vacancy notice. “Although further refinements and improvements will be made, a wide range of job series is included in the corporate recruiting model to onboard new hires, and more are planned,” the report says.

“FDA has created an agency-wide scientific recruitment team to focus on outreach and talent identification to fill critical agency positions,” FDA says. “Corporate recruiting establishes a process designed to announce commonly filled mission-critical positions across an organization on a recurring basis to provide managers with access to qualified candidates on a predictable schedule. Key goals of FDA's corporate recruitment strategy are to reduce the time to hire and streamline administrative procedures. Since 2015, when FDA began this effort, it has launched targeted recruitment strategies for specific occupations (e.g., mathematical statisticians, pharmacologists, toxicologists, chemists, pharmacists) and has successfully used this process to fill positions in these hard-to-fill professions. FDA is currently working on the next round of announcements for each of these five series, and new lists of qualified candidates were made available for each series in early 2018.”

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