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U.S. FDA Revises Nonprescription Drug Regulations

April 14, 2016

The U.S. Food and Drug Administration (FDA) is proposing to amend its nonprescription over-the-counter (OTC) drug regulations.
If finalized as proposed, the rule would supplement the time and extent application (TEA) process for OTC drugs by adding filing determination requirements and criteria and by addressing the withdrawal of consideration of TEA and safety and effectiveness data submissions.
Comments close on June 3, 2016.