The drug diagnostic co-development concept paper

Author:

Hinman L M,Huang S-M,Hackett J,Koch W H,Love P Y,Pennello G,Torres-Cabassa A,Webster C

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology,Genetics,Molecular Medicine

Reference8 articles.

1. Salerno RA, Lesko LJ . Three years of promise, proposals and progress on optimizing the medicines: a Commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop. Pharmacogenomics J 2006; 1: 1–4.

2. FDA/DIA Workshop: Co development of drug, biologic, and device products, July 2004, Arlington, VA, http://www.diahome.org/Content/Events/04040.pdf .

3. Drug-diagnostic co-development – preliminary concept paper, FDA publication, not for implementation: http://www.fda.gov/cder/genomics/pharmacoconceptfn.pdf .

4. Huang S-M . Track 2: introduction: concept paper: drug-diagnostic co-development – introduction: April 12, 2005, Bethesda, MD, http://www.fda.gov/cder/offices/ocpb/workshops.htm .

5. Hinman L . Track 2 industry comments, April 12, 2005, Bethesda, MD, http://www.fda.gov/cder/offices/ocpb/workshops.htm .

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