FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA?s policies for issuing waivers, refunds, or reductions in prescription drug user fees. The newly issued guidance is a revision of a 1993 guidance titled Draft Interim Guidance Document for Waivers of and Reductions in User Fees.
FDA has issued a guidance titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products that outlines FDA’s policies for issuing waivers, refunds, or reductions in prescription drug user fees. The newly issued guidance is a revision of a 1993 guidance titled Draft Interim Guidance Document for Waivers of and Reductions in User Fees.
Under the Prescription Drug User Fee Act (PDUFA), FDA is authorized to assess application fees for certain human drug and biological product applications or supplements. In addition, FDA can assess annual product fees for certain approved drug and biological products, and annual establishment fees for the facilities in which those products are made.
Under PDUFA, FDA will grant a waiver or reduction in fees if an applicant meets the eligibility criteria under one of the following provisions:
The guidance describes the types of waivers and reductions available under the user-fee provisions of PDUFA and describes FDA’s current thinking on the criteria for meeting eligibility requirements for each type of waiver. A section on exemptions and refunds discusses orphan designated products, applications submitted by state or federal government entities, and instances where an application was withdrawn before any substantial work was performed by the agency. The guidance also describes the procedures for requesting waivers, refunds, or reductions, and discusses the procedure for reconsiderations and appeals of FDA decisions on such requests.
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.
Novartis Acquisition of Regulus Therapeutics is Complete
June 25th 2025A key property included in the acquisition is farabursen, an investigational next-generation oligonucleotide targeting the microRNA miR-17 with preferential kidney exposure, intended to treat people with autosomal dominant polycystic kidney disease.