The drug diagnostic co-development concept paper Commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop

Pharmacogenomics Journal

Volumn 6, Issue 6, 2006, Pages 375-380

  Hinman, L M ^a   Huang, S M ^b   Hackett, J ^c   Koch, W H ^d   Love, P Y ^b   Pennello, G ^c   Torres Cabassa, A ^b   Webster, C ^e  

^a HOFFMANN LA ROCHE INC   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^d ROCHE MOLECULAR SYSTEMS   (United States)

^e MILLENNIUM PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

BIOMEDICAL TECHNOLOGY ASSESSMENT; CLINICAL ASSESSMENT; DRUG EFFICACY; DRUG INDUSTRY; DRUG LABELING; DRUG LEGISLATION; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; MANDATORY TESTING; MEDICAL DECISION MAKING; PHARMACOGENOMICS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; VALIDATION PROCESS; WORKSHOP;

CLINICAL TRIALS; DIAGNOSTIC TESTS, ROUTINE; DRUG DESIGN; DRUG INDUSTRY; PHARMACOGENETICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33751370806     PISSN: 1470269X     EISSN: 14731150     Source Type: Journal    
DOI: 10.1038/sj.tpj.6500392     Document Type: Review

References (8)

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/Conten/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 Drug-diagnostic co-development - preliminary concept paper, FDA publication, not for implementation: http://www.fda.gov/cder/genomics/ pharmacoconceptfn.pdf.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-CD 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.
6. Huang S-M, Hinman LM, Webster C, Hackett J, Kock W, Love P et al. Track 2 summary, April 13, 2005, Bethesda, MD, http://www.fda.gov/cder/offices/ ocpb/workshops.htm.
7. Labeling background http://www.fda.gov/ohrms/dockets/ac/05/briefing/ 2005-4194B1_03_Topic-1A.pdf; background information for an advisory committee for pharmaceutical science, clinical pharmacology subcommittee meeting on November 14, 2005; http://www.fda.gov/ ohrms/dockets/ac/05/ slides/2005-419451_Slide-Index.htm.
8. FDA Guidance for Industry: Pharmacogenomic Data Submissions, issued March, 2005. http://www.fda.gov/cder/guidance/6400fnl.htm.