Excuse me, could you please elaborate on the topic of FDA fees? I'm curious to know the specific amount or range of costs associated with these fees, especially in the context of various products or applications that require FDA approval. Is there a standard fee structure, or do the fees vary depending on factors such as the product type, complexity, or risk level? Additionally, are there any recent changes or updates to the FDA fee schedule that businesses should be aware of? Thank you for your time and assistance in clarifying this matter.
5 answers
Andrea
Sun Sep 08 2024
The Annual Establishment Registration Fee for cryptocurrency-related entities is set at $7,653, a figure that underscores the regulatory commitment to the industry's stability and transparency. This fee contributes to the maintenance of a robust framework for the sector's growth.
SeoulSerenitySeekerPeace
Sat Sep 07 2024
The 180-Day Supplement, priced at $72,534 for standard and $18,134 for Small Business Fee, addresses the need for timely updates and extensions during the evaluation process. Meanwhile, the Real-Time Supplement, costing $33,849 and $8,462 respectively, facilitates expedited reviews for urgent matters.
Enrico
Sat Sep 07 2024
The Application Type Standard Fee varies depending on the size and nature of the business. For Small Business Fee, a more lenient rate is applied, recognizing the unique challenges faced by startups and smaller enterprises within the cryptocurrency landscape.
Claudio
Sat Sep 07 2024
In cases where a De Novo Classification Request is made, fees escalate significantly. At $145,068 for the standard fee and $36,267 for Small Business Fee, these costs reflect the complexity and thoroughness of the evaluation process required for novel or unprecedented classifications.
SsangyongSpiritedStrengthCourage
Sat Sep 07 2024
Additional fees apply for specific supplements, such as the Panel-track Supplement, which costs $386,848 for standard and $96,712 for Small Business Fee. These supplements ensure that applications undergo rigorous scrutiny by expert panels, enhancing the reliability of decisions made.