Development of Drugs for Resistant Organisms Presentation to FDA Anti-Infective Drugs Advisory Committee March 5, 2003

Jan 26, 2013

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Development of Drugs for Resistant Pathogens Characteristics to Justify Development. Microbiological SuperiorityInhibit resistant organismsPharmacological AdvantageFrequency of dosingEase of administrationSafety Advantage. Development of Drugs for Resistant Pathogens Preclinical IND Criteria.

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Development of Drugs for Resistant Organisms Presentation to FDA Anti-Infective Drugs Advisory Committee March 5, 2003

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Development of Drugs for Resistant Organisms Presentation to FDA Anti-Infective Drugs Advisory Committee March 5, 2003

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Presentation Transcript

FDA Oncologic Drugs Advisory Committee Pediatric Oncology Subcommittee

FDA Medical Imaging Drugs Advisory Committee

Anti-Infective Drugs Advisory Committee Meeting Clinical Trial Designs for Community Acquired Pneumonia

Arthritis Advisory Committee March 5, 2003

DOSE SELECTION FOR ANTI-INFECTIVE DRUGS: INDUSTRY PERSPECTIVE

FDA Anesthetic &amp; Life Support Drugs Advisory Committee Sept. 10, 2003

Anti-infective Drugs

Update on Congenital Eye Malformations Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting J

Presented by Carl Norden, M.D. at the Anti-Infective Drugs Advisory Committee meeting on October 28, 2003

III.6. Anti-infective Drugs

FDA Anti-Infective Drugs Advisory Committee, October 2003

Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

FDA Advisory Committee March 6, 2003

Antiviral Drugs Advisory Committee Meeting

Ant-Infective Drugs

Presented by Carl Norden, M.D. at the Anti-Infective Drugs Advisory Committee

FDA Endocrine and Metabolic Drugs Advisory Committee October 7, 2003

FDA Advisory Committee for Pharmaceutical Science—March 13, 2003

Development of Drugs for Resistant Pathogens

Peginterferon 2a/Ribavirin FDA Antiviral Drugs Advisory Committee

FDA Advisory Committee January 13, 2003

Psychopharmacologic Drugs Advisory Committee June 16, 2003

FDA Anesthetic & Life Support Drugs Advisory Committee Sept. 10, 2003