The assessment fee is established by the FDA at the beginning of each calendar year.
Similarly, if the drug is undergoing a bioavailability, bioequivalence, or bioactivity study and the sponsor has instituted a new bioavailability, bioequivalence, or bioactivity protocol under 21 CFR 514.23(b)(3)(ii), the DMF holder may avoid incurring a fee. As a general rule, when a drug represents a new chemical entity, the DMF owner may avoid incurring the fee at the time of submission if there are no other patent(s) or other IP restrictions on the drug. However, there are circumstances where a DMF owner may avoid incurring a fee when it initially submits a generic drug application. Generally, a DMF fee must be collected before a DMF is assessed.
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