GDUFA Facility Self-Identification Pace Slow As Deadline Neared
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.
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Fewer fee-paying facilities than estimated self-identified with the agency as part of the launch of the generic drug user fee program, which helped increase the fees about 17% more than anticipated for domestic finished dosage form facilities.
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.
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.