US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies
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<strong>505</strong>(b)(2) RegulationPotential <strong>505</strong>(b)(2) C<strong>and</strong>idates:• Marketed, unapproved (DESI) drug*• PET drugs (FDG F 18, Ammonia N 13, Sodium Fluoride F 18)• Racemates• Known excipients used as active drugs*• New dosage form• Pharmacokinetic alteration• New indication• New combination• Pro-drug of approved drug* May or may not have an RLD
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