GDUFA Facility Fees Likely To Increase Due To Fewer Self-IDs
Executive Summary
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.
You may also be interested in...
FDA’s Sequestered User Fees From FY 2013 Likely Gone, But FY 2014 Fees Could Be Exempted
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.
Hamburg Trumpets Potential Rewards Of Quality Improvement For Generic Industry
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.
GDUFA Self-Identification Woes Can’t Deflate Industry, FDA Enthusiasm
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.