FDA Spending $3 mil. On Compounding Oversight, Maybe More If Authority Expanded
This article was originally published in The Pink Sheet Daily
The agency’s overall funding request, including White Oak construction money, is complicated by the lack of an FY 13 baseline, senators tell Commissioner Hamburg during an Appropriations Subcommittee hearing that focuses mostly on food issues.
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Agency releases 483 forms from a post-crises inspection push; the effort may help FDA illustrate its inspection capabilities to Congress and states and indicate the agency’s oversight plans under the new authority it has proposed.
As the grace period nears its close, industry officials say they expected problems getting generic drug manufacturing facilities to self-identify under the new user fee requirement; meanwhile, FDA expects to hire nearly three times the staff in the Office of Generic Drugs to meet GDUFA commitments.
The inspection focus of the budget request is largely on adding more personnel, but the agency continues to think about how best to target and leverage its resources in its globalization plan.