federal_register: 2014-28828
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-28828 | Patient-Focused Drug Development Public Meeting on Chagas Disease | Notice | The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Chagas disease. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The meeting is intended to allow FDA to obtain patients' perspectives on the impact that Chagas disease has on their daily lives, as well as their perspectives on the available therapies for Chagas disease. FDA is also interested in discussing issues related to scientific challenges in developing drugs to treat Chagas disease. In the afternoon, FDA will provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to treat Chagas disease. The input from this public meeting will help in developing topics for further discussion. | 2014-12-10 | 2014 | 12 | https://www.federalregister.gov/documents/2014/12/10/2014-28828/patient-focused-drug-development-public-meeting-on-chagas-disease | https://www.govinfo.gov/content/pkg/FR-2014-12-10/pdf/2014-28828.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Chagas disease. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth... |