federal_register: 2014-16714
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-16714 | Food and Drug Administration Third Annual Patient Network Meeting; Under the Microscope: Pediatric Drug Development | Notice | The Food and Drug Administration (FDA), Office of Health and Constituent Affairs (OHCA) is announcing a 1-day meeting to explore challenges related to pediatric product development. The meeting will serve as a forum for FDA's stakeholders (patients, caregivers, patient advocates, healthcare professional groups, the general public, academia, and industry) to learn about regulations that encourage pediatric product development; to discuss ways to advance pediatric product development, how health disparities impact pediatric product development, the importance of transparency in pediatric clinical trials, and how analysis of information from failed pediatric clinical trials might improve future designs for pediatric trials; and to identify ways patient input can benefit clinical trial design for pediatric trials. The 1-day meeting will also provide an opportunity to participate in panel discussions on the challenges related to development of products used to treat pediatric patients, including pediatric patients with rare diseases and explore ways that patients/caregivers, FDA, and industry may work together to incorporate patient input in future pediatric product development and regulatory decisionmaking. | 2014-07-16 | 2014 | 7 | https://www.federalregister.gov/documents/2014/07/16/2014-16714/food-and-drug-administration-third-annual-patient-network-meeting-under-the-microscope-pediatric | https://www.govinfo.gov/content/pkg/FR-2014-07-16/pdf/2014-16714.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA), Office of Health and Constituent Affairs (OHCA) is announcing a 1-day meeting to explore challenges related to pediatric product development. The meeting will serve as a forum for FDA's stakeholders (patients,... |