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                Guidance, Compliance, & Regulatory Information

Guidance, Compliance, & Regulatory Information

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          Sunscreen Innovation Act (SIA)Guidance, Compliance, & Regulatory Information Sunscreen Innovation Act (SIA)
  
  	
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    PrintThe Sunscreen Innovation Act (SIA) was enacted on November 26, 2014 to provide an alternative process for the review of safety and effectiveness of nonprescription sunscreen active ingredients.
The SIA supplements the FDA’s Time and Extent Application (TEA) regulation with new statutory procedures. The SIA also requires FDA to establish timeframes for review of TEAs for OTC drugs other than sunscreen active ingredients.Public CommunicationFDA Voice Blog: FDA's Sunscreen Guidance outlines safety and effectiveness data needed for new active ingredientsFrom our perspective: Helping to Ensure the safety and effectiveness of sunscreensImplementing the SIARegulatory Policy InformationMeetingsSunscreen meetingsAdditional Background InformationFDA Voice Blog: Shedding some light on FDA�s review of sunscreen ingredients and the Sunscreen Innovation ActRulemaking History for OTC Sunscreen Drug ProductsConsumer Information on Sunscreen

                                                                                  Content current as of:
      11/22/2016Guidance, Compliance, & Regulatory Information

          
                        Good Review Practices | GRPs


                        Guidances | Drugs
          Electronic Drug Registration and Listing System (eDRLS)
          CDER FOIA Electronic Reading Room
          CDER International Program
          Enforcement Activities | FDA
          Human Drug Compounding
          Human Drug Exports
          Human Drug Imports
          Laws, Acts, and Rules
          Postmarketing Requirements and Commitments: Introduction
          Surveillance: Post Drug-Approval Activities
 
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