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02/08/07
AdvaMed's Draft Statement for FDA Public Meeting on In Vitro Diagnostic Multivariate Index Assays (pdf)
01/22/07
AdvaMed's Comments submitted to FDA, concerning Draft Guidance for Industry and FDA Staff; Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems (pdf)
11/21/06
AdvaMed’s Comments on Draft Guidance for Industry and FDA Staff: Pharmacogenetic Tests and Genetic Tests for Heritable Markers (pdf)
05/10/06
AdvaMed’s comments submitted to FDA concerning agency’s Draft Guidance for Industry and FDA Staff: Pharmacogenetic Tests and Genetic Tests for Heritable Markers (pdf)
01/03/06
AdvaMed’s Comments submitted to FDA on Draft Guidance on Collection of Platelets through Automated Methods (pdf)
07/15/05
AdvaMed’s submitted comments on FDA’s concept paper on diagnostic testing with a drug or biological therapy (pdf)
07/22/04
AdvaMed comments on Therapeutic Goods Order No. 34 Standard for Diagnostics of Human Origin (TGO 34) (pdf)
06/2003
AdvaMed comments on new regulatory framework for IVD discussion paper proposed by Australian TGA (pdf)
(Clinical Laboratory Improvement Amendments of 1988 )
12/06/05
AdvaMed comments submitted to FDA on Draft Guidance for Industry and Staff –Recommendations on Waiver Applications under Clinical Laboratory Improvement Amendments of 1988 (pdf)
09/07/05
CLIA waiver guidance document - Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications - Draft Guidance for Industry and FDA Staff. (pdf)
08/11/06
AdvaMed Submits Comments on Clinical Trials Policy Reconsideration
05/12/06
Laboratory Diagnostics Bill Introduced In House
04/07/06
HHS Advisory Committee Releases Report on Reimbursement of Genetic Tests and Services
02/09/06
AHRQ Releases Proposed Outline for Registry Guidance and Comparative Effectiveness Review on Noninvasive Diagnostic Tests for Breast Abnormalities
02/06/06
Administration Releases FY 2007 Budget
08/03/05
CMS Proposes Increased Payment for Flow Cytometry and Coverage and Appeals Process Changes
01/25/05
CMS Receptive to AdvaMed Position and Recommendations for Reforming CMS Processes for New Clinical Lab Tests
