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FDA Finalizes Rule on Over-the-Counter Time and Extent Applications of Drugs

December 13, 2016

The US Food and Drug Administration (FDA) has finalized the rule on over-the-counter time and extent applications of drugs. Specifically, FDA amends the nonprescription (over-the-counter or OTC) drug regulations

The final rule specifies the time and extent application (TEA) process for OTC drugs. This final rule establishes the timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA).

Aside from this, this final rule changes the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient.

This rule will become effective on December 23, 2016.

Source URL: Final Rule: Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications