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CDER - Sunscreens Marketed Under the OTC Monograph System Webinar - September 19, 2011

The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series will highlight various aspects of drug regulation.
These focused webinars will support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.
On Monday, September 19, 2011, we presented our webinar entitled Sunscreens Marketed Under the OTC Monograph System which discussed marketing requirements for OTC sunscreen products in light of the new sunscreen regulations that published on June 17, 2011. Because these regulations cover OTC sunscreens marketed under the OTC monograph system, a general overview of the OTC monograph system was presented. Then, the presentation covered each of the three sunscreen regulations (a final rule, a proposed rule, and an advance notice of proposed rulemaking) that published on June 17, 2011 and the draft guidance on enforcement policy that accompanied these publications. The presentation focused on the testing and labeling requirements in the final rule. 
Dr. Reynold Tan was our presenter. Dr. Tan is an interdisciplinary scientist in FDA’s Office of Drug Evaluation IV/Division of Nonprescription Regulation Development at the Food and Drug Administration.

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