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IDSA Introduction to FDA Commissioner Gottlieb (PDF)
As you assume this important role, I want to offer the Infectious Diseases Society of America (IDSA) as a resource and a partner for advancing policies to improve patient...
http://www.idsociety.org/.../IDSA Introduction to FDA Commissioner Gottlieb (... - 5 pages

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IDSA Comments on FDA Notice of Meeting on Microbiology Devices Panel (PDF)
IDSA greatly appreciates this opportunity to provide comments. We urge the FDA to classify viral load tests for these transplant associated viruses as Class II. Over the...
http://www.idsociety.org/.../IDSA Comments on FDA Notice of Meeting on Microb... - 3 pages

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IDSA Comments to FDA on Laboratory Developed Tests (LDT) Discussion Paper (PDF)
Our society has closely followed the FDA’s draft guidance, public stakeholder workshop, and January 2017 discussion paper proposing to regulate laboratory developed tests...
http://www.idsociety.org/.../IDSA Comments to FDA on Laboratory Developed Tes... - 3 pages

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IDSA Leads Response to FDA Guidance on Next Generation Sequencing (PDF)
Thank you for the opportunity to submit written comments on the draft guidance entitled “Infectious The American Society for Microbiology (ASM) is the largest single life...
http://www.idsociety.org/.../IDSA Leads Response to FDA Guidance on Next Gene... - 7 pages

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IDSA Comments to FDA on Emergency Use Authorizations (PDF)
As illustrated by the recent enterovirus D68, Ebola virus disease, and Zika virus outbreaks, IDSA understands the clear and present danger posed by emerging infections and...
http://www.idsociety.org/.../IDSA Comments to FDA on Emergency Use Authorizat... - 3 pages

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IDSA, ASM, and PASCV Letter to FDA on LDTs (PDF)
Our societies have closely followed the FDA’s draft guidance proposing to regulate laboratory developed tests (LDTs), and are deeply concerned that the regulations will...
http://www.idsociety.org/.../IDSA, ASM, and PASCV Letter to FDA on LDTs (PDF)... - 3 pages

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IDSA Shares Evidence on Diagnostics for Transplant Viruses with FDA (PDF)
However our society remains concerned that the FDA’s draft guidance to regulate laboratory developed tests (LDTs) will negatively impact the care of patients being evaluated...
http://www.idsociety.org/.../IDSA Shares Evidence on Diagnostics for Transpla... - 4 pages

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IDSA Comments on CMS Proposed Clinical Laboratory Fee Schedule Rule (PDF)
Protecting Access to Medicare Act of 2014 (PAMA). We recognize that CMS is committed to developing an equitable payment system that will improve patient access to diagnosti...
http://www.idsociety.org/.../IDSA Comments on CMS Proposed Clinical Laborator... - 4 pages

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IDSA Comments on CARB Diagnostics Challenge (PDF)
IDSA has worked tirelessly to address the public health crisis of antimicrobial resistance for more than a decade, beginning with our 2004 Bad Bugs, No Drugs report. Plan...
http://www.idsociety.org/.../IDSA Comments on CARB Diagnostics Challenge (PDF... - 7 pages

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IDSA Engages House 21st Century Cures Initiative (PDF)
Antibiotics are generally accepted as the greatest curative development of the 20th century and now credited with a 26 year increase in average longevity. This progress is...
http://www.idsociety.org/.../IDSA Engages House 21st Century Cures Initiative... - 11 pages

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