The term essentially a copy of an approved drug means (A) a drug that is identical or nearly identical to an approved drug, or a marketed drug not subject to section 503(b) and not subject to approval in an application submitted under section 505, unless, in the case of an approved drug, the drug appears on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing (section 503B(d)(2)(A) of the FDCA [21 U.S.C
As this is mentioned before, this research method is highly cost-effective and do not require a large grant or sponsors but requires only a few consumables and travelling expenses such as for conferences
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Key points by region: United States: Not FDA approved
Therefore, antiviral drugs are selected in the early stages of chronic hepatitis B