federal_register: 2016-10913
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| 2016-10913 | Clinical Trial Design Considerations for Malaria Drug Development Media; Public Workshop | Notice | The Food and Drug Administration (FDA) is announcing a public workshop regarding clinical trial design considerations for malaria drug development. FDA is interested in discussing the scientific challenges pertaining to malaria drug development and malaria parasite detection methods used as endpoints in clinical trials. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government agencies, public health organizations, academic experts, and industry on various aspects of the design of clinical trials evaluating new drugs to treat malaria. The input from this public workshop will also help in developing topics for future discussion. Dates and Times: The public workshop will be held on June 30, 2016, from 8:30 a.m. to 4 p.m. Location: The public workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Bldg. 31 Great Rm., Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/ BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Seating is limited and available only on a first-come, first-served basis. Contact Persons: Ms. Lori Benner and/or Ms. Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 22, Rm. 6221, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1300. Registration: Registration is free for the public workshop. Interested parties are encouraged to register early. Seating will be available on a first-come, first-served basis. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) to Malariaworkshop2016@fda.hhs.gov. Persons without access to the Internet can call 301-796-1300 to register. Persons needing a sign language interpreter or other special accommodations should notify Ms. Jessica Barnes or Ms. Lori Benner (see Contact Persons) at least 7 days in advance. | 2016-05-10 | 2016 | 5 | https://www.federalregister.gov/documents/2016/05/10/2016-10913/clinical-trial-design-considerations-for-malaria-drug-development-media-public-workshop | https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10913.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing a public workshop regarding clinical trial design considerations for malaria drug development. FDA is interested in discussing the scientific challenges pertaining to malaria drug development and... |