2012 Prescription Drug User Fees Announced
In late July, FDA announced the 2012 user fees collected under the Prescription Drug User Fee Act (PDUFA) of 2007. The act stipulates that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of three categories: applications for approval of drug and biological products, establishments where the products are made, and drug and biological products. In some instances, the fees can be waived, reduced, or refunded, as spelled out in an FDA draft guidance issued in March 2011.
In late July, FDA announced the 2012 user fees collected under the Prescription Drug User Fee Act (PDUFA) of 2007. The act stipulates that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of three categories: applications for approval of drug and biological products, establishments where the products are made, and drug and biological products. In some instances, the fees can be waived, reduced, or refunded, as spelled out in an FDA draft guidance issued in March 2011.
The fees are calculated using the fee base revenue amount for fiscal year (FY) 2008 published in the Federal Register of Oct. 12, 2007 (72 FR 58103) adjusted for the FY 2009, FY 2010, FY 2011, and FY 2012 drug-safety increases, for inflation, for workload, for excess collections through FY 2011, and for a final-year adjustment. Rates for 2011 and 2012 are listed below:
- For applications requiring clinical data, the FY 2011 fees were $1,542,000. FY 2012 fees will be $1,841,500, a 19.42% increase.
- For applications that do not require clinical data, the FY 2011 fees were $771,000. FY 2012 fees will be $920,750, a 19.42% increase.
- For supplements requiring clinical data, the FY 2011 fees were $771,000. FY 2012 fees will be $920,750, a 19.42% increase.
- Establishment fees for FY 2011 were $497,200. FY 2012 fees will be $520,100, a 4.6% increase.
- Product fees for FY 2011 were $86.520. FY 2012 fees will be $98,970, a 14.3% increase.
These fees are effective on Oct. 1, 2011, and will remain in effect through Sept. 30, 2012.
For related stories see:
FDA Issues Draft Guidance on User-Fee Waivers, Reductions, and Refunds
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
