FDA Boosts User Fees 17-19% for FY 2007
The US Food and Drug Administration announced its Prescription Drug User Fee Amendments of 2002 (PDUFA II) fees schedule for fiscal year 2007 (Oct. 1, 2006 - Sept. 30, 2007), including increases ranging from 17% to 19%.
In an Aug. 2 Federal Register announcement (1), the US Food and Drug Administration (Rockville, MD, www.fda.gov) announced its Prescription Drug User Fee Amendments of 2002 (PDUFA III) fees for fiscal year 2007 (Oct. 1, 2006–Sept. 30, 2007). The new fee schedule for drug and biological products will be:
- $896,200 for an application requiring clinical data, up 17% from $767,400 for FY 2006;
- $448,100 for an application not requiring clinical data or a supplement requiring clinical data, up 17% from $383,700;
- $313,100 for establishment fees, up 19% from $264,000;
- $49,750 for product fees, up 18% from $42,130.
The agency will begin issuing invoices for establishment and product fees under the new schedule this month.
Reference
1. US Food and Drug Administration, "Prescription Drug User Fee Rates for Fiscal Year 2007," Federal Register 71 (148), 43780–43784 (Aug. 2, 2006). DOCID:fr02au06-96.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
