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Letters, Testimony & Comments

Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
February 27 2013
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
February 4 2013
BIO Comments on ANVISA Public Consultation N°66/2012
BIO respectfully submits both questions and comments for the National Health Surveillance Agency’s (ANVISA) consideration on the...
February 1 2013
IRB: BIO Comments on Draft Guidance for IRBs
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
January 22 2013
Accelerated Approval: BIO Comments on pCR in Neoadjuvant Treatment for Breast Cancer
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
July 29 2012
Clinical Trials: BIO Submits Comments on FDA's Modernizing the Regulation of Clinical Trials
Dear Sir/Madam: BIO thanks the FDA for the opportunity to provide comments on Modernizing the Regulation of Clinical Trials and...
May 30 2012
DDI: BIO Comments on FDA's Draft Guidance for Industry Drug Interaction Studies
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA)...
May 20 2012
BIO's Testimony to the House Appropriations, Labor HHS Subcommittee on the President's FY 2013 Budget Request for the National Institutes of Health (NIH)
Good morning Chairman Rehberg, Ranking Member DeLauro, Members of the Committee, ladies, and gentlemen. I am Scott Koenig, President and...
March 20 2012
Orphan Drugs: BIO Submits Comments on Orphan Drug Regulations
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
January 17 2012
Risk-Based Monitoring: BIO Comments on Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
November 28 2011
BIO Statement to the Presidential Commission for the Study of Bioethical Issues: Principles Regarding Ethical Performance of International Clinical Trials
November 16, 2011
Given by Russell M. Medford, MD, PhD President and CEO, Salutria Pharmaceuticals, LLC BIO Board Standing Committee on Bioethics Co-...
November 16 2011
Human Subject Research Protections: BIO Comments on HHS ANPRM on Human Subjects Research Protections (Common Rule)
  Dear Dr. Menikoff:     The Biotechnology Industry Organization (BIO) thanks the Department of Health and Human...
October 26 2011
BIO Requests for FY 2012 Agriculture, Rural Development, FDA and Related Agencies Appropriations Act
May 12, 2011
Dear Chairman Kingston and Ranking Member Farr: On behalf of the Biotechnology Industry Organization (BIO), I am writing to encourage...
May 12 2011
BIO Statement for the Institute of Medicine Committee on Pediatric Studies Conducted under BPCA and PREA
April 28, 2011
BIO Statement for the Institute of Medicine Committee on Pediatric Studies Conducted under BPCA and PREA April 28, 2011 The...
April 28 2011
BIO's Comments on the Centers for Medicare and Medicaid Services' (CMS) Proposed Decision Memorandum for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer
April 28, 2011
The Biotechnology Industry Organization (BIO) thanks the Institute of Medicine (IOM) for the opportunity to comment on the successes and...
April 28 2011
Biotech Leader Provides Testimony at Congressional Hearing on SBIR/STTR Renewal
April 7, 2011
Hearing Testimony Scott Koenig, M.D., PH.D. Before the House of Representatives Committee on Small Business Good morning Chairman...
April 7 2011
The American Research and Competitiveness Act: BIO supports the Research and Development Tax Credit
March 24, 2011
On behalf of the Biotechnology Industry Organization (BIO) and its more than 1,100 member companies, academic institutions, state...
March 24 2011
BIO Submits Comments on FDA’s Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination
February 14, 2011
Re: Docket No. FDA–2010–D–0616 Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational...
February 14 2011
BIO Comments on FDA’s Draft Guidance for Industry on Qualification Process for Drug Development Tools
January 24, 2011
Re: Docket No. FDA–2010–D–0529 Draft Guidance for Industry on Qualification Process for Drug Development Tools;...
January 24 2011
BIO Comments on Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies
December 28, 2010
Re: Docket No. FDA-2010-D-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational...
December 28 2010
Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials
November 8, 2010
Re: Docket No. FDA-2010-D-0451: Draft Guidance for Industry on Suicidality: ProspectiveAssessment of Occurrence in Clinical Trials...
November 8 2010
NIH: Objectivity in Research for Which Public Health Funding Is Sought
July 20, 2010
BIO long has argued that actual and potential conflicts of interest in research should be identified, disclosed, and appropriately...
July 20 2010
Draft Guidance on Assessment of Abuse Potential of Drugs
March 29, 2010
March 29 2010
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
March 8, 2010
March 8 2010
Draft Guidance, Clinical Considerations for Therapeutic Cancer Vaccines
December 17, 2009
December 17 2009
Providing Effective Information to Consumers about Prescription Drug Risks and Benefits
November 25, 2009
November 25 2009
Oral Statement to the Institute of Medicine Committee on Accelerating Rare Disease Research and Orphan Product Development
November 23, 2009
November 23 2009
Postmarketing Studies and Clinical Trials -- Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act
October 13, 2009
October 13 2009
Expansion of the Clinical Trial Registry and Results Data Bank
June 22, 2009
Re: Docket No. NIH-2009-0002: Public Meeting on Expansion of the Clinical Trial Registry and Results Data Bank   Introduction...
June 22 2009
BIO Statement to the Secretary's Advisory Committee on Genetics, Health & Society
May 15, 2009
May 15 2009
EMEA's draft guideline "The Requirements for First-in-Human Clinical Trials for Potential High Risk Medicinal Products"
May 23, 2007
The Biotechnology Industry Organization (BIO) submits these comments on the European Medicines Agency’s (EMEA’s) draft...
May 23 2007
BIO Comments on Draft Guidance on the Pediatric Research Equity Act
November 5, 2005
November 5 2005
Comments on Draft Guidance on Computerized Systems in Clinical Trials
January 5, 2005
Docket No. 2004D-0440, Federal Register: October 4th, 2004 (Volume 69, Pages 59239-59240).
January 5 2005
Comments on CMS's Draft Decision Memorandum for Anticancer Chemotherapy for Colorectal Cancer
December 23, 2004
December 23 2004
The Role of Universities in Biotech Product Development and Capacity Building
November 20, 2004
Janna Tom, Assistant Director, Office of Technology Transfer, University of California; Vice President for Public Policy, Association of...
November 20 2004
BIO's Comments to FDA's Proposed Rule on Institutional Review Board (IRB) Registration Requirements
September 27, 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
September 27 2004
Comments on Proposed Rule on Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
September 8, 2004
September 8th, 2004 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville,...
September 8 2004
Suggestions for research priorities to AHRQ
July 1, 2004
In response to §1013 of the Medicare Prescription Drug, Improvement, and Modernization Act.
July 1 2004
BIO Letter of Support for H.R. 2857, the Pediatric Research Equity Act of 2003
September 17, 2003
The Honorable James Greenwood 2436 Rayburn House Office Building U.S. House of Representatives Washington, DC 20515 The Honorable...
September 17 2003
Testimony of Charles A. Johnson, MBChB
April 23, 2002
Good morning, Mr. Chairman and Members of the Committee. My name is Dr. Charles Johnson. I am Associate Director of Specialty...
April 23 2002
Cures Acceleration Network: BIO Strongly Supports the CAN Program
On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for $500 million for Cures...

Letters, Testimony & Comments

Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products
February 27 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
February 4 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
BIO Comments on ANVISA Public Consultation N°66/2012
February 1 2013
BIO respectfully submits both questions and comments for the National Health Surveillance Agency’s (ANVISA) consideration on the...
IRB: BIO Comments on Draft Guidance for IRBs
January 22 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
Accelerated Approval: BIO Comments on pCR in Neoadjuvant Treatment for Breast Cancer
July 29 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
More Letters, Testimony & Comments →

Press Releases

IFPMA, BIO and WADA Advance Anti-Doping Collaboration with the Launch of 2 Fields 1 Goal Campaign
July 23 2012
Groups Issue Booklet to Help Biotechnology and Pharmaceutical Companies Identify Pipeline Medicines with Doping...
BIO Supports Permanent Reauthorization of Programs to Encourage Development of Lifesaving Medications for Children
March 28 2012
Washington, D.C. (March 28, 2012) – BIO President and CEO Jim Greenwood issued the following statement in...
BIO Statement on New Bill to Extend Therapeutic Discovery Project Tax Credit
May 25 2011
WASHINGTON, D.C. (Wednesday, May 25, 2011) - Biotechnology Industry Organization (BIO) President and CEO Jim...
Representative Upton Honored as BIO Legislator of the Year
May 4 2011
WASHINGTON, D.C. (Tuesday, May 04, 2011) - The Biotechnology Industry Organization (BIO) announced today its...
Senator Casey Honored as BIO Legislator of the Year
May 4 2011
Pennsylvania Bio President Christopher Molineaux and BIO President and CEO Jim Greenwood present Senator...
More Press Releases →