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FDA Unveils User Fee Rates for 2017
August 2, 2016
In the late 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for the US Food and Drug Administration (FDA) itself.
The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a timely manner. The solution FDA proposed was to collect fees from the companies it regulates for each new product, which would provide the agency with a substantial source of funding to boost its staff and reduce review times.
Eventually, this led to the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, which authorized FDA to collect such fees for its review activities in return for a speedier, more predictable review process.
Since then, Congress has reauthorized the user fee acts to enable FDA to collect fees for other regulated products, including medical devices, biosimilars, and generic and animal drugs.
FY 2017 Fees
For FY 2017, FDA has lowered most of its application fees, while increasing some of its other fees, such as facility fees for certain products.
For new drugs and biosimilars, fees are down across the board from 2016, and are at their lowest point since FY2013. For new drug applications requiring clinical data, FDA has lowered the fee by more than $300,000, from $2,374,200 in FY2016 to $2,038,100 in FY2017.
Medical device makers will also get a significant break on fees in FY2017, with nearly all fees down to their lowest point under the 2012 Medical Device User Fee Amendments (MDUFA II). FDA on Monday also released new guidance on small business qualification and certification.
For generic drugmakers, FY 2017 fees will be slightly lower than in FY 2016, though fees for drug master files, finished dosage forms and active pharmaceutical ingredients have all increased.
Prescription Drug User Fee Act (PDUFA) | 2017 | 2016 | 2015 |
---|---|---|---|
New Drug Application (With Clinical Data) | $2,038,100 | $2,374,200 | $2,335,200 |
New Drug Application (Without Clinical Data) | $1,019,050 | $1,187,100 | $1,167,600 |
New Drug Application Supplement With Clinical Data | $1,019,050 | $1,187,100 | $1,167,600 |
NDA Establishment | $512,200 | $585,200 | $569,200 |
Annual Product Registration | $97,750 | $114,450 | $110,370 |
Medical Device User Fee Act (MDUFA) [Small Business] | 2017 | 2016 | 2015 |
Premarket Application | $234,495 [$58,624] | $261,388 [$65,374] | $250,895 |
Product Development Protocol | $234,495 [$58,624] | $261,388 [$65,374] | $250,895 |
Biologics Licensing Application | $234,495 [$58,624] | $261,388 [$65,374] | $250,895 |
Premarket Report | $234,495 [$58,624] | $261,388 [$65,374] | $250,895 |
BLA Efficacy Supplement | $234,495 [$58,624] | $261,388 [$65,374] | $250,895 |
Panel-Track Supplement | $175,871 [$43,968] | $196,041 [$49,010] | $188,171 |
180-Day Supplement | $35,174 [$8,794] | $39,208 [$9,802] | $37,634 |
Real-Time Supplement | $16,415 [$4,104] | $18,297 [$4,574] | $17,563 |
510(k) Premarket Notification Submission | 4,690 [$2,345] | $5,228 [$2,614] | $5,018 |
30-Day Notice | $3,752 [$1,876] | $4,182 [$2,091] | $4,014 |
513(g) Request for Classification Information | $3,166 [$1,583] | $3,529 [$1,765] | $3,387 |
Annual Fee for Class III Device | $8,207 [$2,052] | $9,149 [$2,287] | $8,781 |
Annual Establishment Registration | $3,382 [$3,382] | $3,845 [$3,845] | $3,646 |
Generic Drug User Fee Act (GDUFA) | 2017 | 2016 | 2015 |
Abbreviated New Drug Application | $70,480 | $76,030 | $58,730 |
Prior Approval Supplement | $35,240 | $38,020 | $29,370 |
Drug Master File | $51,140 | $42,170 | $26,720 |
Finished Dosage Form Facility (Domestic) | $258,646 | $243,905 | $247,717 |
Finished Dosage Form Facility (Foreign) | $273,647 | $258,905 | $262,717 |
Active Pharmaceutical Ingredient Facility (Domestic) | $44,234 | $40,867 | $41,926 |
Active Pharmaceutical Ingredient Facility (Foreign) | $59,234 | $55,867 | $56,926 |
Biosimilar User Fee Act (BsUFA) | 2017 | 2016 | 2015 |
Biosimilar Application (Requiring Clinical Data) | $2,038,810 | $2,374,200 | $2,335,200 |
Biosimilar Application (Not Requiring Clinical Data) | $1,019,050 | $1,187,100 | $1,167,600 |
Biosimilar Supplement (Requiring Clinical Data) | $1,019,050 | $1,187,100 | $1,167,600 |
Biological Product Development (Initial) | $203,810 | $237,420 | $233,520 |
Biological Product Development (Annual) | $203,810 | $237,420 | $233,520 |
Biological Product Development (Reactivation) | $407,620 | $474,840 | $467,040 |
Establishment Fee | $512,200 | $585,200 | $569,200 |
Product Fee | $97,750 | $114,450 | $110,370 |
Animal Drug User Fee Act (ADUFA) | 2017 | 2016 | 2015 |
Animal Drug Application (New) | $350,700 | $351,100 | $400,600 |
Animal Drug Application (Supplement) | $175,350 | $175,550 | $200,300 |
Animal Drug Product Fee | $8,195 | $7,790 | $8,075 |
Animal Drug Establishment Fee | $111,900 | $105,950 | $104,150 |
Animal Drug Sponsor Fee | $103,100 | $101,000 | $94,450 |
Animal Generic Drug User Fee Act (AGDUFA) | 2017 | 2016 | 2015 |
Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) | $232,400 | $233,300 | $189,200 |
Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) | $116,200 | $116,650 | $94,600 |
Generic New Animal Drug Product Fee | $10,200 | $8,705 | $8,500 |
Sponsor Fee (Seven or More Approved Products) | $96,350 | $83,800 | $80,900 |
Sponsor Fee (Three or More Approved Products) | $72,263 | $62,850 | $60,675 |
Sponsor Fee (One or Fewer Approved Products) | $48,175 | $41,900 | $40,450 |
Outsourcing Facility Fee | 2017 | 2016 | 2015 |
Qualified Small Business Establishment Fee | $5,279 | $5,203 | $5,103 |
Non-Small Business Establishment Fee | $16,852 | $16,465 | $16,442 |
Reinspection Fee | $15,837 | $15,610 | $15,308 |
Source: RAPS