FDA Hearing on Antimicrobial Resistance
The Food and Drug Administration has issued a notice announcing that it will hold a public hearing on antimicrobial resistance on April 28, 2008 in Rockville, MD.
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(Section 1112 (Orphan Antibiotic Drugs) of the Food and Drug Administration Amendments Act requires the Commissioner of Food and Drugs to convene a public hearing to discuss which serious and life-threatening infectious diseases, such as diseases caused by gram-negative bacteria and other diseases due to antibiotic-resistant bacteria, potentially qualify for available grants and contracts under section 5(a) of the Orphan Drug Act (21 USC 360ee(a)) or other incentives.)
FDA Seeks Information, Recommendations on Antimicrobial Resistance
The FDA is seeking general information about the problem of antimicrobial resistance, recommendations as to possible approaches to contain the problem of antimicrobial resistance, responses to specific questions, and other pertinent information from interested parties.
The FDA specifically invites comments on: (1) strategies that should be considered to limit the development of antimicrobial resistance, and studies that could be done to assess the utility, safety and effectiveness of those strategies; (2) the possible utility and effectiveness of economic incentives in promoting drug development for antimicrobial resistant organisms.
(See FDA notice for a complete list of topics for comment.)
-comments are due by May 26, 2008
FDA contact - Nancy Stanisic (301) 827-1660
FDA notice (D/N FDA-2008-N-0225, FR Pub 04/15/08) available at http://edocket.access.gpo.gov/2008/pdf/08-1129.pdf