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Personalized Medicine

Drugs Need Friends Too
January 19, 2012

Drugs approved with companion diagnostic tests represent the next wave of personalized...

Laurence Marton on Personalized Medicine
November 29, 2011

BIOtech-NOW talks to Laurence Marton, Co-Chair of the Personalized Medicine World Conference...

Hillary Theakston, The Clearity Foundation
June 2, 2011

BIOtechNOW’s Tracy Cooley talks to Hillary Theakston, of ...

Recommendations for Novel Diagnostics Coverage and Reimbursement
May 25, 2011

Some of the most pressing challenges for the advent of personalized medicine relate to the...

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Letters, Testimony & Comments

Companion Diagnostics: BIO Comments on FDA Draft Guidance
October 14 2011
RE: Comments Regarding the Draft Guidance on In Vitro Companion Diagnostic Devices; FDA-2011-D-0215 Dear Sir/Madam: The Biotechnology...
BIO Comments on FDA Draft Guidance: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only
September 1 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration...
BIO Comments Following FDA Public Meeting: Ultra High Throughput Sequencing for Clinical Diagnostic Applications
July 23 2011
BIO commends the FDA for prospectively seeking input from industry to ensure that the regulatory environment is supportive of the rapid...
BIO Comments on the FDA's Draft Guidance for the Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies
April 19 2011
RE: Docket No. FDA-2011-D-0082: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical...
FDA: Oversight of Laboratory Developed Tests (LDT)
August 15 2010
BIO's comments to the FDA regarding LDT oversight.BIO represents companies that developed and manufacture LDTs consequently BIO...
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Press Releases

TREAT Act Offers Renewed Hope for Patients
February 15 2012
Washington, DC (February 15, 2012) – Today, the Biotechnology Industry Organization (BIO) praised Sen. Kay...
Challenges in Reimbursement Hamper Development of Novel Diagnostics
January 6 2011
WASHINGTON, D.C. (Thursday, January 06, 2011) - The Biotechnology Industry Organization (BIO) released today a report...
Media Registration for the 2011 BIO International Convention Now Available Online
January 3 2011
WASHINGTON, D.C. (Monday, January 03, 2011) - The Biotechnology Industry Organization (BIO) announced today that...
BIO Hails Court of Appeals Action to Lift Injunction on Embryonic Stem Cell Research
September 29 2010
WASHINGTON, D.C. (Wednesday, September 29, 2010) - Biotechnology Industry Organization (BIO) President and CEO Jim...
New BIO Report Highlights Value of Biotechnology to Individuals and Society
May 4 2010
 WASHINGTON, D.C. (May 4, 2010) --  A new report issued by the Biotechnology Industry Organization...
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