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It does not need preclinical and clinical trials but need to show bioequivalence by way of bioavailability and bioequivalence experiments. The ANDA contents and evaluation method are outlined based on the Typical Technical Doc format in 5 top quality, nonclinical, and scientific modules.24 of the chapter. This type of medical investigation is not r
The sponsor shall post an authentic and two copies of all submissions on the IND file, such as the unique submission and all amendments and experiences.(ii) Oblique fees contain expenditures incurred principally to supply the drug for professional sale (e.g., costs for services and products accustomed to manufacture the supply of investigational dr
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