GDUFA Facility Fees Likely To Increase Due To Fewer Self-IDs
Fewer API and finished dosage form facilities appear on the FY 2014 generic drug user fee self-identification list, meaning FDA may be forced to adjust next year’s GDUFA fees for more than just inflation.
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Rep. Farr says Congressional Budget Office scoring problems could not be overcome, meaning FY 2013 FDA user fees lost to sequester may not be recovered, but amendment will be proposed to ensure FY 2014 fees are not lost in the upcoming appropriations bill.
FDA Commissioner takes a softer tone in repeating the message that quality must improve in the generics industry, saying the reward may manifest in inspection policy.
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.