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U.S. Food and Drug Administration (FDA) has drafted guidance for industry on the innovative approaches to be used in ensuring the safety and effectiveness of nonprescription drug products.

This draft guidance describes two innovative approaches to demonstrate safety and effectiveness of nonprescription drug products:

  • Development of labeling in addition to the DFL
  • Implementation of additional conditions so that consumers appropriately self-select and use the product

Nonprescription drug products must comply with applicable labeling requirements for over-the-counter (OTC) drug products under 21 CFR part 201, including, but not limited to the format and content requirements for OTC drug product labeling under § 201.66.

A consultation is open for this draft until September 17, 2018.

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