Home » Health Care

Letters, Testimony & Comments

BIO Comments on New CMS Clinical Lab Fee Schedule Codes and Payment Determinations
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical...
October 4 2012
Companion Diagnostics: BIO Comments on FDA Draft Guidance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RE: Comments Regarding the Draft Guidance on In Vitro Companion Diagnostic Devices; FDA-2011-D-0215 Dear Sir/Madam: The Biotechnology...
October 14 2011
BIO Comments on FDA Draft Guidance: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only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...
September 1 2011
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...
July 23 2011
BIO Comments on the FDA's Draft Guidance for the Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies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RE: Docket No. FDA-2011-D-0082: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical...
April 19 2011
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...
August 15 2010
NIH: A Plan to Develop the Genetic Testing Registry
August 2, 2010
BIO supports the view that a system of genetic test registration is necessary to provide stakeholders with information about the spectrum...
August 2 2010
Clinical Trials: BIO Submits Comments on the Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics
May 27, 2010
Re: FDA–2010–D–0090: Adaptive Design Clinical Trials for Drugs and Biologics Dear Sir/Madam: The Biotechnology...
May 27 2010
BIO’s testimony to the Maryland Health and Government Operations Committee opposing House Bill 1155 the Prescription Confidentiality Act
March 12, 2009
House Health and Government Operations Committee March 12, 2009 House Bill 1155-Prescription Confidentiality Act BIO opposes House...
March 12 2009
HHS Action Plan to Prevent Healthcare-Associated Infections
February 6, 2009
Re: FR Doc. E8-31195: HHS Action Plan to Prevent Healthcare-Associated Infections To whom it may concern: The Biotechnology Industry...
February 6 2009
BIO Final Comments to DC on Licensure of Pharmaceutical Detailers
July 24, 2008
Subject: Department of Health, Chapter 83, Pharmaceutical Detailers, of Title 17, Business Occupations and Professions, of the District...
July 24 2008
Steps Tricare Management Activity (TMA) has taken to implement a new rebate regime
April 10, 2008
Re: Dear Manufacturer Letter Dated February 1, 2008 Dear General Granger: The Biotechnology Industry Organization (BIO) appreciates...
April 10 2008
The US System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of HHS
December 21, 2007
BIO's comments on the SACGHS draft report
December 21 2007
Comments regarding In Vitro Diagnostic Multivariate Index Assays (IVDMIAs)
August 27, 2007
Re: Docket No. 2006D-0347, Federal Register: July 26, 2007 (Volume 72, Pages 41081- 41083) Dear Sir/Madam, The following comments...
August 27 2007
Proposed Decision Memorandum for Second Reconsideration of the Medicare Clinical Trial Policy
August 17, 2007
BIO's comments on the CMS' Proposed Decision Memorandum.
August 17 2007
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays (IVDMIA)
August 7, 2007
BIO's Comments on the FDA's Draft Guidance
August 7 2007
Use of Medication Guides to Distribute Drug Risk Information to Patients
July 11, 2007
Re: Docket No. 2007N–0121: Use of Medication Guides to Distribute Drug Risk Information to Patients Dear Sir or Madam: The...
July 11 2007
Realizing the Promise of Pharmacogenomics: Opportunities and Challenges
June 1, 2007
BIO's Comments on the SACGHS draft report.
June 1 2007
BIO CEO Letter Opposing Importation
June 7, 2004
Dear Majority Leader Frist: We, the undersigned biotechnology executives, strongly oppose further efforts to legalize prescription drug...
June 7 2004
BIO Comments on Pharmacogenomic Data Submissions
February 2, 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
February 2 2004
Letter from 53 Senators Opposed to Importation
June 24, 2003
Dear Chairman Thomas, Tauzin and Grassley: As conference begins on reconciling the differences between the House and Senate versions of...
June 24 2003

Letters, Testimony & Comments

BIO Comments on New CMS Clinical Lab Fee Schedule Codes and Payment Determinations
October 4 2012
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical...
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...
More Letters, Testimony & Comments →

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...
More Press Releases →