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U.S. Department of Health and Human Services

Drugs

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Regulation of Nonprescription Drug Products – Question and Answer Sessions. August 4-5, 2014

 

Information:
The Division of Clinical Evaluation (DNCE) and Division of Nonprescription Drug Regulation (DNRD) held two live Question & Answer (Q&A) sessions on the regulation of nonprescription drug products [also known as over-the-counter (OTC) drugs]. The purpose of these sessions was to address questions on the regulation of nonprescription drug products via the New Drug Application (NDA) and the OTC Monograph Process pathways, and the OTC drug facts label. Questions regarding specific drug products, applications, or specific monographs was not addressed in these sessions.
 
  • Interested participants are strongly recommended to view the following pre-recorded webinar (approximately 30 minutes) on the “Regulation of Nonprescription Drug Products”:
    https://collaboration.fda.gov/p7bq7qtqvbn/ 
 
 
CDER plans to post archived webcasts after the sessions, however, in cases where transmission was not successful or other technical issues arise, archived webcasts will not be available.
 
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