Sequester, Shutdown Hurt FDA Recruitment, Morale – Hamburg
This article was originally published in The Rose Sheet
The FDA commissioner tells a House subcommittee that a job candidate questioned whether the “uncertainty” of government work was worth leaving academia, reflecting sentiment that challenges the agency’s efforts to fill senior leadership positions.
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The federal shutdown interrupts FDA’s increasing enforcement against firms marketing violative supplement products in addition to slowing drug application evaluations and facility inspections. FDA would retain 8,180 staff members, about 55% of its total, mostly because they could be “paid from carryover funding.”
With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.
CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.