Agency’s Charge - Prof. P. Tulkens (ISAP)
Recent Meetings Involving Agency Discussion of PK/PD of Anti-Infectives
Recent Meetings Involving Agency Discussion of PK/PD of Anti-Infectives (cont.)
DRAFT Guidance Documents for Industry - Developing Antimicrobial Drugs: General Considerations for Clinical Trials and Individual Indications
July 1998 DAIDP Advisory Committee DRAFT Guidance Documents for Industry - Developing Antimicrobial Drugs: General Considerations for Clinical Trials and Individual Indications
July 1998 DAIDP Advisory Committee (cont.)
October 1998 DAIDP Advisory Committee Development of Drugs for Resistant Bacteria, Including Selective Spectrum Agents
October 1998 DAIDP Advisory Committee (cont.)
March 1999 FDA/ISAP Workshop Pharmacodynamics and the Impact on Anti-Infective and Anti-Viral Drug Development
March 1999 FDA/ISAP Workshop (cont.)
FDA Review Division Organization
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