Module 6

04/10/2024

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USA – Switch applications

 DATA REQUIREMENTS

 Both efficacy and safety data

 Demonstrating that the drug product is safe to use in the nonprescription setting.  Show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.

 Provide post-marketing safety surveillance data.

The Organisation for Professionals in Regulatory Affairs

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USA – Switch applications  Approval… When FDA decides…

 …that the previous prescription status is “ not necessary for the protection of the public health by reason of the drug’s toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and . . . the drug is safe and effective for use in self-medication as directed in proposed labeling .”  21 CFR 310.200(b).

The Organisation for Professionals in Regulatory Affairs

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