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FDA & Regulatory

Technology and Regulatory Affairs Department

AdvaMed's Technology and Regulatory Affairs (T&R) department works to ensure that patients have timely access to needed medical technologies. Our goal is to ensure that regulatory processes, especially those involving the Food and Drug Administration (FDA), are reasonable and predictable and result in science-based decisions. We work with members to develop pre-market approval policies that speed patient access to new technologies, ensure reasonable post-market and inspection programs, develop a legislative agenda, and to coordinate on international regulatory efforts.

Inside this section...

AdvaMed Announces
AdvaMed’s Interventional Cardiology Working Group Plays Important Role in Drug-Eluting Stent Issues
Industry's Input Included in Report from HHS Secretary's Advisory Committee on Genetics, Health and Society
FDA Forms Public-Private Partnership to Streamline Clinical Trials
 

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Diagnostics News


Presentations from
12/11/08 IVD
Roundtable Meeting

Presentations
from
9/9/08 Workshop of
24-Hour Ambient Hold
of Whole Blood:  What
Have We Learned?
(.zip file format)

ABC Follow-up
Presentation to BPAC
on 24-Hour Workshop
(.pdf file format)
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Presentations
 from
6/13/08 FDA-Industry
IVD Roundtable
(.zip file format)
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Presentations from
2/6/08 PGx
Roundtable
(.zip file format)