Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public Workshop

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2011-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), Office of Pediatric Therapeutics, is announcing a public workshop entitled “Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures.” There is a critical need for pediatric research on medical countermeasures to ensure that these products are safe and effective in the pediatric population. The challenges to developing and evaluating drugs, biologics, and devices for children in the medical countermeasure context are complex ( printed page 2557) and need to be better understood by ethicists, researchers, policymakers, and the general public. The purpose of the public workshop is to provide a forum for careful consideration of scientific, ethical, and regulatory issues confronting FDA and other stakeholders in the area of medical countermeasures and public health preparedness. Date and Time: The public workshop will be held on February 15, 2012, from 8:30 a.m. to 5 p.m. and February 16, 2012, from 8:30 a.m. to 3 p.m. Location: The public workshop will be held at the Rockville Hilton Hotel, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Cindy de Sales, (240) 316-3207, FAX: (240) 316-3201, email: cindy@tepgevents.com . Registration: Please use the following Web site to register online: http://www.contractmeeting…