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federal_register: 2015-04376

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-04376 Pediatric Neurocognitive Workshop; Advancing the Development of Pediatric Therapeutics Public Workshop Notice The Food and Drug Administration's (FDA) Division of Gastroenterology and Inborn Errors Products Division and Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, and the Office of Pediatric Therapeutics in the Office of the Commissioner are announcing a 2-day public workshop. Day 1 of the workshop is entitled "Assessment of Neurocognitive Outcomes in the Inborn Errors of Metabolism". Day 2 of the workshop is entitled, "Advancing the Development of Pediatric Therapeutics: Assessment of Pediatric Neurocognitive Outcomes". The purpose of this 2-day workshop is to provide a forum to consider issues related to advancing pediatric regulatory science in the evaluation of neurocognitive outcomes in pediatric patients. 2015-03-03 2015 3 https://www.federalregister.gov/documents/2015/03/03/2015-04376/pediatric-neurocognitive-workshop-advancing-the-development-of-pediatric-therapeutics-public https://www.govinfo.gov/content/pkg/FR-2015-03-03/pdf/2015-04376.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration's (FDA) Division of Gastroenterology and Inborn Errors Products Division and Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, and the Office of Pediatric Therapeutics in the...  

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