federal_register: 2016-05621
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-05621 | Advancing the Development of Pediatric Therapeutics: Successes and Challenges of Performing Long-Term Pediatric Safety Studies; Public Workshop | Notice | The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics (OPT) and Center for Drug Evaluation and Research are announcing a 2-day public workshop entitled "Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies." The purpose of this 2- day public workshop is for FDA to have an open discussion with experts in the field examining the need and path forward for long-term pediatric safety studies. Day 1 of the public workshop will focus on an exposition of the successes and challenges of long-term safety studies in children. Day 2 of the public workshop will focus on suggestions for the future on study design and implementation of long-term safety studies in children. Viewpoints of patient representatives of children with chronic conditions and industry will be included. | 2016-03-14 | 2016 | 3 | https://www.federalregister.gov/documents/2016/03/14/2016-05621/advancing-the-development-of-pediatric-therapeutics-successes-and-challenges-of-performing-long-term | https://www.govinfo.gov/content/pkg/FR-2016-03-14/pdf/2016-05621.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics (OPT) and Center for Drug Evaluation and Research are announcing a 2-day public workshop entitled "Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and... |