Letters, Testimony & Comments

The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on two draft guidance release on October 3,...
February 5 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the "Notification of Comment Period...
July 23 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a...
July 10 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical...
October 4 2012
RE: Comments Regarding the Draft Guidance on In Vitro Companion Diagnostic Devices; FDA-2011-D-0215 Dear Sir/Madam: The Biotechnology...
October 14 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration...
September 1 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
RE: Docket No. FDA-2011-D-0082: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical...
April 19 2011
BIO's comments to the FDA regarding LDT oversight.BIO represents companies that developed and manufacture LDTs consequently BIO...
August 15 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
Re: FDA–2010–D–0090: Adaptive Design Clinical Trials for Drugs and Biologics Dear Sir/Madam: The Biotechnology...
May 27 2010
House Health and Government Operations Committee March 12, 2009 House Bill 1155-Prescription Confidentiality Act BIO opposes House...
March 12 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
Subject: Department of Health, Chapter 83, Pharmaceutical Detailers, of Title 17, Business Occupations and Professions, of the District...
July 24 2008
Re: Dear Manufacturer Letter Dated February 1, 2008 Dear General Granger: The Biotechnology Industry Organization (BIO) appreciates...
April 10 2008
BIO's comments on the SACGHS draft report
December 21 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
BIO's comments on the CMS' Proposed Decision Memorandum.
August 17 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
BIO's Comments on the SACGHS draft report.
June 1 2007
Dear Majority Leader Frist: We, the undersigned biotechnology executives, strongly oppose further efforts to legalize prescription drug...
June 7 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
February 2 2004
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

December 9 2015
The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS) Proposed Rule entitled Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System.  
April 20 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments in association with FDA's public meeting entitled Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.
February 5 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on two draft guidance release on October 3, 2014, entitled Framework for Regulatory Oversight of Laboratory Developed Tests (the "Framework Guidance") and FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) (the "Notification Guidance) (Collectively the "LDT Guidance").
July 23 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the "Notification of Comment Period- 2013 Gapfill Payment Amounts Clinical Laboratory Fee Schedule (CLFS)" published by the Centers for Medicare and Medicaid Services (CMS) on May 9, 2013.
July 10 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a knowledge-intensive economy.

Press Releases

February 26 2016
Washington, D.C. (February 26, 2016) – The Biotechnology Innovation Organization (BIO) Executive Vice President for Health Policy Dan Durham released the following statement regarding yesterday’s White House announcement of actions to accelerate the Precision Medicine Initiative:
April 29 2015
Washington, D.C. (April 29, 2015) – The Biotechnology Industry Organization (BIO) today releases the following statement on the 21st Century Cures Initiative discussion draft shared by Chairman Fred Upton (R-MI), Rep. Diana DeGette (D-CO), Rep. Frank Pallone, Jr. (D-NJ), Rep. Joe Pitts (R-PA), and Rep. Gene Green (D-TX). 
February 15 2012
The bill will modernize the FDA and accelerate patient access to cures and new treatments.
January 6 2011
BIO releases a report by Health Advances on the limitations of the nation’s reimbursement system for novel diagnostics and the impact of these limitations. 
January 3 2011
The 2011 BIO International Convention will highlight the latest trends and the newest opportunities for executives, investors, scientists, policy leaders, and media from around the world.