Thatβs nothing at all and is a normal part of the IND application process. The FDA collects fees from the companies to comp for the massive amount of man-hours that go into reviewing their data, inspections, audits, etc. Iβm not saying itβs not abused, but thatβs the reason given. Even small companies get assessed applying for IND approval.
Thatβs nothing at all and is a normal part of the IND application process. The FDA collects fees from the companies to comp for the massive amount of man-hours that go into reviewing their data, inspections, audits, etc. Iβm not saying itβs not abused, but thatβs the reason given. Even small companies get assessed applying for IND approval.
https://www.fda.gov/industry/prescription-drug-user-fee-amendments/standard-costs-thousands-dollars-components-process-review-human-drug-applications