Letters, Testimony & Comments

 Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity...
February 3 2014
 Dear Commissioner Hamburg and Director Burwell: On behalf of the member companies of Biotechnology Industry Organization (BIO),...
January 22 2014
 Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity...
January 3 2014
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
November 18 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
November 5 2013
BIO appreciates this fourth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory...
October 16 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
September 23 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
September 16 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
September 13 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
September 13 2013
Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
August 26 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
July 29 2013
Re: Docket No. FDA–2013–N–050: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies; Notice of Public...
July 25 2013
Biologics are complex medicines that are manufactured using living organisms.  Due to their size and complexity, biologics are...
July 8 2013
In general, the Draft Guidance is well written and provides very useful clarification of the implementation of FDA’s regulations on...
July 8 2013
Re: Docket No. FDA–2013-D-0401: Draft Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design...
June 24 2013
A concerted effort through the TTIP to unleash the potential of biotechnology in the Transatlantic economy and beyond will go a long way...
June 19 2013
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations...
June 19 2013
Countries across the globe are realizing the significant impact rare diseases have on their populations, and are responding by putting...
June 7 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 8 2013
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency...
March 14 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
February 19 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments on...
February 4 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
January 22 2013
  Re:Docket No. FDA-2011-N-0090: Proposed Rule: Unique Device Identification System Dear Sir/Madam: The Biotechnology Industry...
November 7 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
July 7 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 11 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 8 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 8 2012
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name...
March 29 2012
February 22, 2012 Texas Health and Human Services Commission Attn: Stacey Johnston Policy Analyst Medicaid/Children’s Health...
March 1 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency...
February 21 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
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to...
December 2 2011
Re: Docket No. FDA–2011-D-0530: Draft Guidance for Industry and Food and Drug Administration Staff on MobileMedical Applications...
October 19 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
September 19 2011
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
September 1 2011
Re: Docket No. FDA-2010-D-0530:  Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves...
August 15 2011
Re: Docket No. FDA-2010-D-0246: Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems Dear Sir...
November 1 2010
Dear Ms. Maloy, As President and CEO of the Biotechnology Industry Organization (BIO) and on behalf of our more than 1,100...
September 30 2010
BIO responded to the GAO request for feedback regarding the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act....
August 13 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
Senate Finance Committee Member: On behalf of the Biotechnology Industry Organization (BIO) I am writing to state our opposition to...
June 7 2010
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
Re: New Rule 560-12-1-.14 “Withdrawals from Inventory.” Proposed further changes to adopted Rule 560-12-1-.14, entitled...
September 5 2008
TESTIMONY OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE JUDICIARY COMMITTEE OF THE UNITED STATES SENATE IMPORTATION OF...
July 14 2004
Dear Majority Leader Frist: We, the undersigned biotechnology executives, strongly oppose further efforts to legalize prescription drug...
June 7 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
TESTIMONY OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE COMMITTEE ON HEALTH, EDUCATION, LABOR, & PENSIONS OF THE...
May 20 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
November 3rd, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
November 3 2003
October 13, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
October 13 2003
The Honorable J. Dennis Hastert 235 Cannon House Office Building U.S. House of Representatives Washington DC 20510 Dear Speaker...
July 15 2003
Dear Chairman Thomas, Tauzin and Grassley: As conference begins on reconciling the differences between the House and Senate versions of...
June 24 2003
The Honorable Mark B. McClellan Commissioner United States Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville,...
February 14 2003
March 4 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Request for Nominations: Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.”
February 3 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act.”
January 22 2014
On behalf of the member companies of Biotechnology Industry Organization (BIO), we respectfully request that the Office of Management and Budget (OMB) issue the proposed Food and Drug Administration (FDA) regulation on the electronic distribution of prescribing information for human drugs and biologics. Once implemented, the rule will provide patients, providers, and caregivers with timely access to the most up-to-date prescribing information to inform the safe use of FDA-approved therapies.
January 3 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Proposed Rule: Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products.”
November 18 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products.”  
May 24 2013
Rx Response elevates to Alert status to address potential impact from Moore tornado on supply chain.
July 23 2012
Groups issue booklet to help biotechnology and pharmaceutical companies identify pipeline medicines with doping potential.
June 28 2011
BIO announced its endorsement of the “Joint Declaration on Cooperation in the Fight against Doping in Sport” between the World Anti-Doping Agency (WADA) and the International Federation of Pharmaceutical Manufactures and Associations (IFPMA).
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.