Food and Drug Administration
Anti-Infective Drugs Advisory Committee
February 20, 2002
Discussion Topic: Approaches to the development of antimicrobial agents for the treatment of resistant pathogens
Developing Drugs for Resistant Pathogens, CDER, FDA pdf doc
Appended References and Selected Readings
Bax RP. Antibiotic resistance: a view from the pharmaceutical industry. Clin Infect Dis 1997; Jan; 24 Suppl 1:S151-3.
Billstein SA. How the pharmaceutical industry brings an antibiotic drug to market in the United States. Antimicrob Agents Chemother 1994 Dec;38(12):2679-82.
Cohen M. Epidemiology of drug resistance: implications for a post-antimicrobial era. Science 1992 Aug 21;257(5073):1050-5.
Georgopapadakou NH. Infectious disease 2000: drug resistance and new drugs. Drug Resist Updat 2000 Oct;3(5):265-269.
Hancock RE. The role of fundamental research and biotechnology in finding solutions to the global problem of antibiotic resistance. Clin Infect Dis 1997 Jan;24 Suppl 1:S148-50.
House of Lords, Science and Technology - Seventh Report. Chapter 6, New drug development. Source: http://www.parliament.the-stationery-office.co.uk/pa/ld199798/ldselect/ldsctech/081vii/st0701.htm.
Moellering RC Jr. Antibiotic resistance: lessons for the future. Clin Infect Dis 1998 Aug;27 Suppl 1:S135-40; discussion S141-2.
Silver LL, Bostian KA. Discovery and development of new antibiotics: the problem of antibiotic resistance. Antimicrob Agents Chemother 1993 Mar;37(3):377-83.
Tenover FC. Development and spread of bacterial resistance to antimicrobial agents: an overview. Clin Infect Dis 2001 Sep 15;33 Suppl 3:S108-15.
Williams RJ. Globalization of antimicrobial resistance: epidemiological challenges. Clin Infect Dis 2001 Sep 15;33 Suppl 3:S116-7.
Walsh C. Molecular mechanisms that confer antibacterial drug resistance. Nature 2000 Aug 17;406(6797):775-81.
Whitney CG, Farley MM, Hadler J, Harrison LH, Lexau C, Reingold A, Lefkowitz L, Cieslak PR, Cetron M, Zell ER, Jorgensen JH, Schuchat A; Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Increasing prevalence of multidrug-resistant Streptococcus pneumoniae in the United States. N Engl J Med 2000 Dec 28;343(26):1917-24.