Fee waiver 2019 and Categorical exclusion
Fee waiver 2019The company has re-applied for a fee waiver for 2019 and received positive answer from US-FDA again, as for fiscal years 2017 and 2018. This means that also for 2019, the company must not pay the very high fee for a running application to the FDA. The fee waiver is granted as a result of the MUMS determination (Minor Use Minor Species) for the product. Categorical exclusion for environmental assessmentPanion has also applied to US-FDA for claiming a so-called “Categorical Exclusion” (CE) under 21 CFR 25.33(e) for the investigational use of CG-01-canine with regards to