Letters, Testimony & Comments
Dear Majority Leader Reid and Minority Leader McConnell:
On behalf of the Biotechnology Industry Organization (BIO) and its more than 1...
March 16 2012
William D. Waddill, Senior Vice President and Chief Financial Officer OncoMed Pharmaceuticals highlights the importance of capital...
March 6 2012
February 22, 2012
Texas Health and Human Services Commission
Attn: Stacey Johnston
Policy Analyst
Medicaid/Children’s Health...
March 1 2012
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments...
February 29 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to comment on...
February 29 2012
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency...
February 21 2012
Re: Request for Comments Regarding Enhancements to the Part C and Part D Plan Ratings
The Biotechnology Industry Organization (BIO)...
January 20 2012
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
January 17 2012
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA...
January 9 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
December 23 2011
Dear Sir/Madam:
On behalf of the Biotechnology Industry Organization, thank you for the opportunity to comment on the proposed user fee...
December 16 2011
These comments are submitted by the Biotechnology Industry Organization (BIO) in response to the United States Department of Agriculture...
December 13 2011
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to...
December 2 2011
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
November 28 2011
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RE: Comments Regarding the Draft Guidance on In Vitro Companion Diagnostic Devices; FDA-2011-D-0215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
September 30, 2011
Re: Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient...
September 30 2011
September 1, 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration...
September 1 2011
September 1, 2011
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
September 1 2011
August 9, 2011
The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the core set of health quality measures for the...
August 9 2011
July 25, 2011
BIO supports policies that emphasize disclosure of financial interests, rather than prohibiting certain relationships. It is important to...
July 25 2011
June 9, 2011
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
June 9 2011
May 17, 2011
Dear Chairman Frelinghuysen and Ranking Member Visclosky:
On behalf of the Biotechnology Industry Organization (BIO), I am writing to...
May 17 2011
April 18, 2011
Re: Docket No. FDA-2011-D-0057: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic...
April 18 2011
April 1, 2011
Re: Request for Comments on the Strategy for American Innovation
Subject: Innovation Strategy RFI
Email: competitiveness@doc.gov
Dear...
April 1 2011
March 24, 2011
March 24, 2011
As our economy begins to improve, job creation remains a critical priority toward ensuring a broad, deep and sustained...
March 24 2011
February 1, 2011
"An Act establishing procedures for sampling plants protected by patent or other intellectual property laws; requiring mediation of...
February 1 2011
October 29, 2010
BIO submitted comments on FDA’s "Development and Distribution of Patient Medication Information for Prescription Drugs."...
October 29 2010
October 14, 2010
October 14, 2010
To: Members of the Ad Hoc Open-ended Working Group on Access and Benefit-sharing of the Convention on Biological...
October 14 2010
August 16, 2010
BIO recommends that each grandfathered health plan disclose which insurance products it offers and cover preventive services and vaccines...
August 16 2010
August 3, 2010
BIO advocated for the recently enacted new Therapeutic Discovery Project Credit program, which was created as a unique opportunity for...
August 3 2010
July 20, 2010
BIO’s comments on FDA Transparency Task Force’s Draft Proposals for Public Comment Regarding Disclosure Policies. BIO agrees...
July 20 2010
July 15, 2010
BIO submitted comments on the Annex 2, Revision 2, of the European GMP Guide: Manufacture of Biological Medicinal Products for Human Use...
July 15 2010
June 21, 2010
Re: Medicare Coverage Gap Discount Program Model Manufacturer Agreement – [CMS-4151-NC] RIN 0938-AQ04
Dear Administrator Tavenner...
June 21 2010
June 7, 2010
Senate Finance Committee Member:
On behalf of the Biotechnology Industry Organization (BIO) I am writing to state our opposition to...
June 7 2010
June 1, 2010
Dear Chairman Inouye and Ranking Member Cochran:
As the Senate debates fiscal year 2011 federal funding, the undersigned organizations...
June 1 2010
May 31, 2010
Re: FDA–2010– N–0218: Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the...
May 31 2010
May 27, 2010
BIO proposes that the guidance make it more clear which methods are being proposed, as early as possible and consistently throughout the...
May 27 2010
May 27, 2010
Re: FDA–2010–D–0090: Adaptive Design Clinical Trials for Drugs and Biologics
Dear Sir/Madam:
The Biotechnology...
May 27 2010
May 27, 2010
Access to Early Capital
In the United States and globally, commercial development of biotechnology relies on the continuing...
May 27 2010
January 26, 2010
Office of Medicine, Science, and Public Health
Office of the Assistant Secretary for Preparedness and Response,
FAO Jessica Tucker, Ph....
January 26 2010
December 14, 2009
Comments on the “Rule Requiring Use of Best Management Practices for Growing Crops to Minimize Cross Contamination”
Dear...
December 14 2009
November 3, 2009
Dear Ms. Blue,
This letter is submitted by the Biotechnology Industry Organization (BIO) in response to the request for public comment...
November 3 2009
October 8, 2009
Recommendations in the Secretary’s Advisory Committee on Genetics, Health and Society draft report on Gene Patenting and Licensing...
October 8 2009
September 29, 2009
RE: SEC Release No. 34-60611
Dear Deputy Secretary Harmon:
On behalf of its members, the Biotechnology Industry Organization (“...
September 29 2009
August 25, 2009
Re: Docket No. FDA- 2008-D-0253. Presenting Risk Information in Prescription
Drug and Medical Device Promotion
Dear Sir/...
August 25 2009
August 5, 2009
Re: Docket No. FDA-2009-N-0247, Food and Drug Administration Transparency Task Force, Public Meeting
Dear Sir/Madam:
The...
August 5 2009
July 31, 2009
VIEWS AND PROPOSALS
OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO) AND
THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF...
July 31 2009
July 27, 2009
Re: Docket No. FDA-2009-D-0179, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological...
July 27 2009
July 15, 2009
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property...
July 15 2009
July 7, 2009
Re: Docket No. NIH-2008-0002 RIN 0925-AA53, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health...
July 7 2009
July 1, 2009
Re: Docket No. FDA- 2009-D-0132
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
July 1 2009
June 30, 2009
Re: Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List; Federal Register...
June 30 2009
June 30, 2009
Re: Docket Ref. EMEA/410/01-Rev. 4
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the European Medicines...
June 30 2009
April 30, 2009
Written Testimony of
The Biotechnology Industry Organization (BIO)
Before the United States House of Representatives...
April 30 2009
April 23, 2009
Good morning Chairman Wu, Ranking Member Smith, Members of the Committee, ladies and gentleman. I am Jim Greenwood, President and CEO of...
April 23 2009
April 13, 2009
Re: Docket No. FDA-2009-D-0675, OC 20091.
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
April 13 2009
March 27, 2009
Re: Docket No. FDA-2008-N-0612, OC 2008312. Sentinel Initiative: Structure,
Function, and Scope; Public Workshop
Dear Sir/...
March 27 2009
March 23, 2009
Re: Docket No. FDA- 2009-D-2007. Animal Models - Essential Elements to Address Efficacy Under the Animal Rule
Dear Sir/Madam:
The...
March 23 2009
March 10, 2009
Written Testimony of
The Biotechnology Industry Organization (BIO)
Before the United States Senate
Committee on the...
March 10 2009
January 23, 2009
Re: BIO submits comments to EITF 08-1
Dear Mr. Golden:
On behalf of its members, the Biotechnology Industry Organization (“BIO...
January 23 2009
January 21, 2009
Re: Docket No. FDA-2008-D-0559, Draft Guidance for Industry on Process Validation:
General Principles and Practices; Availability...
January 21 2009
December 17, 2008
IDEAS FOR REFORM OF THE UNITED STATES PATENT AND TRADEMARK OFFICE
Dear President-Elect Obama:
Congratulations on your historic...
December 17 2008
November 25, 2008
Re: Docket No. FDA-2008-D-0514: End-of-Phase 2A Meetings
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the...
November 25 2008
November 3, 2008
Re: Docket No. FDA-2008-D-0386: International Conference on Harmonisation; Draft
Guidance on E2F Development Safety Update Report;...
November 3 2008
October 31, 2008
Re: Draft Annex 11 “Computerised Systems”
Dear Sir/Madam,
The Biotechnology Industry Organization (BIO) appreciates the...
October 31 2008
October 31, 2008
Re: Section 102 Certificate Requirements
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Consumer Product...
October 31 2008
October 27, 2008
Dear Chairman Cox:
On behalf of its members, the Biotechnology Industry Organization (“BIO”) is pleased to provide comments...
October 27 2008
October 6, 2008
Re: Docket No. FDA-2008-D-0417: Draft Guidance for the Public and FDA Staff on
Convening Advisory Committee Meetings; Availability...
October 6 2008
September 26, 2008
Re: OMB control number 0910-0616, Docket No. FDA-2008-N-0144, Agency
Information Collection Activities; Submission for Office of...
September 26 2008
September 8, 2008
Re: BIO Comments Regarding Expansion of the ClinicalTrials.gov Database
Dear Dr. Zarin and Dr. Morton:
The Biotechnology Industry...
September 8 2008
August 27, 2008
Re: FDA Docket 2006N-0467: Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy...
August 27 2008
August 25, 2008
Re: DoH Call for Comments 08/2008
Dear Sir or Madam:
The Biotechnology Industry Organization (BIO) appreciates the opportunity to...
August 25 2008
July 31, 2008
Re: FDA Docket 2008N–0281: Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting
Dear Sir/Madam:...
July 31 2008
June 19, 2008
Re: FDA Docket 2008N–0257: Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment
Dear Sir...
June 19 2008
June 6, 2008
Re: Docket No. FDA–2008N–0234: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies...
June 6 2008
May 30, 2008
RE: Concept Paper on a Guideline on the Chemical and Pharmaceutical Quality Documentation Concerning Biological Investigational Medicinal...
May 30 2008
May 2, 2008
Dear Chairman Pallone and Ranking Member Deal:
On behalf of the Biotechnology Industry Organization (BIO), I am writing to thank you...
May 2 2008
February 7, 2006
Supporting the Genetic Information Nondiscrimination Act (GINA)
February 7 2006
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
July 14, 2004
TESTIMONY OF THE
BIOTECHNOLOGY INDUSTRY ORGANIZATION
BEFORE
THE JUDICIARY COMMITTEE
OF THE
UNITED STATES SENATE
IMPORTATION OF...
July 14 2004
June 1, 2004
Re: Docket No. 2004N-0115
Request for Comment on Prescription Drug Importation
Dear Dr. Carmona and Members of the HHS Task Force on...
June 1 2004
May 20, 2004
TESTIMONY OF THE
BIOTECHNOLOGY INDUSTRY ORGANIZATION
BEFORE
THE COMMITTEE ON
HEALTH, EDUCATION, LABOR, & PENSIONS
OF THE...
May 20 2004
April 14, 2004
April 14, 2004, 9:00 a.m. -5:00 p.m.
Natcher Auditorium, Building 45, National Institutes of Health (NIH)
9000 Rockville Pike,...
April 14 2004
March 25, 2004
March 25 2004
April 15, 2003
Leon R. Kass, M.D., Chairman
The President's Council on Bioethics
1801 Pennsylvania Avenue, NW
Suite 800
Washington, DC 20005...
April 15 2003
May 9, 2002
Good morning, ladies and gentlemen. My name is Carl Feldbaum, and I'm here today to talk about the major political and regulatory forces...
May 9 2002
Dear Dr. Sim:
The following comments are provided by the Biotechnology Industry Organization
(BIO). BIO represents more than 1,000...
BIO advocated for a provision in financial services reform that would ease regulatory burdens for small public biotechnology companies....
Dear Chairman Schapiro:
The Biotechnology Industry Organization (BIO) thanks the Securities and Exchange Commission (SEC or Commission)...
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on the proposed regulations to implement...
Letters, Testimony & Comments
March 16 2012
Dear Majority Leader Reid and Minority Leader McConnell:
On behalf of the Biotechnology Industry Organization (BIO) and its more than 1...
March 6 2012
William D. Waddill, Senior Vice President and Chief Financial Officer OncoMed Pharmaceuticals highlights the importance of capital...
March 1 2012
February 22, 2012
Texas Health and Human Services Commission
Attn: Stacey Johnston
Policy Analyst
Medicaid/Children’s Health...
February 29 2012
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments...
February 29 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to comment on...
Press Releases
April 26 2012
Farm Bill energy programs are helping revitalize rural America and build new agricultural markets; funding for these...
April 24 2012
WASHINGTON, D.C. (April 25, 2012) – The Biotechnology Industry Organization (BIO) announced today its selection...
April 24 2012
WASHINGTON, D.C. (April 25, 2012) – The Biotechnology Industry Organization (BIO) announced today its selection...
April 24 2012
WASHINGTON, D.C. (April 25, 2012) – The Biotechnology Industry Organization (BIO) announced today its selection...
April 24 2012
WASHINGTON, D.C. (April 25, 2012) – The Biotechnology Industry Organization (BIO) announced today its selection...
Receive our newsletter from BIOtechNow
Business Solutions Sponsor
