GDUFA: Will Industry Self-Identification Push Lengthen The Backlog?
This article was originally published in The Pink Sheet Daily
Facility list generated by industry submission likely will include plants that need to be inspected, potentially creating a larger backlog for FDA to clear, but GPhA expects remaining generic drug user fees should be announced by the Jan. 14 deadline.
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FDA is again relying on sponsor self-reporting as it launches GDUFA II.
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.
API, finished dosage form and other facilities in the generic drug supply chain must submit information to FDA by Dec. 3. As of Nov. 18, about one-third had complied, potentially affecting user fee amounts.