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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E7-21713 Adolescent Over-the-Counter Drug Product Use; Public Workshop Notice The Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Consumer Healthcare Product Association (CHPA) are announcing a public workshop entitled "Adolescent Over-the-Counter (OTC) Drug Product Use." The purpose of the workshop is to gain an understanding of current use of OTC drug products by adolescents, including adolescent decisionmaking skills (compared with adult skills) and other factors influencing adolescent OTC drug product use. Information gathered at the workshop and from submitted comments will be used to identify when it would be most appropriate for consumer studies on OTC drugs to enroll adolescents, and to define the type of consumer research and study designs needed to support OTC drug product approval in the adolescent population. The workshop is intended to help inform FDA in its effort to assure the safe and effective use of OTC drug products by adolescents. 2007-11-05 2007 11 https://www.federalregister.gov/documents/2007/11/05/E7-21713/adolescent-over-the-counter-drug-product-use-public-workshop https://www.govinfo.gov/content/pkg/FR-2007-11-05/pdf/E7-21713.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Consumer Healthcare Product Association (CHPA) are announcing a public workshop entitled "Adolescent Over-the-Counter (OTC) Drug Product Use." The purpose of the...

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