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AASLD-FDA-NIH-PhRMA- Hepatotoxicity Special Interest Group Meeting

     

2008 Presentations

Meeting Agenda 

Abstracts and Presenter Biosketches are linked through the presenter's name, presentations are linked through the presentation title.

Introductions and Brief Opening Statements: 
Welcome Statements [PDF]
Janet Woodcock, FDA/CDER; Alan Goldhammer, PhRMA; John Vierling, AASLD;

 

Session I: Moderator, Paul Watkins, UNC; Watkins' Opening Remarks [PDF]

     Session IA: When should an investigational drug be stopped during a trial? 

     Session IB: Tools to help decide if cases are important or drug-induced 

 

Session II:Moderator, Paul Seligman, FDA/CDER; Seligman's Opening Remarks [PDF]

     Session IIA: Should rechallenge be used to prove the drug caused the reaction? 

     Session IIB: Ethical, management, and regulatory issues 

 

Session III: Moderator, John Pears, AstraZeneca; Pears' Opening Remarks for IIIA [PDF]

     Session IIIA: Should patients with stable underlying liver disease be included? 

     Session IIIB: Can we find a truly predictive biomarker to prevent serious adverse reactions? 

 

Public statements on the draft guidance: Lana Pauls, FDA/CDER (coordinator);

Free copies of some articles cited in the abstracts can be obtained by going through PubMed. More information can be found at the PubMed How to Get the Journal Article page.

Contact list for Authors.