Letters, Testimony & Comments

December 16, 2010
Re: Parallel Review of Medical Products [FDA-2010-N-0308] Dear Dr. Berwick and Dr. Hamburg: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the notice and request for comments from the Centers for...
December 7, 2010
Re: IPR and Technology discussions at Cancún Climate Change Talks Dear Secretary Clinton and Ambassador Stern: At this very moment, language is circulating at the UNFCCC climate change meeting in Cancún that proposes to continue...
December 6, 2010
Re: APHIS-2010-0047: Availability of an Environmental Assessment for Supplemental Request for Partial Deregulation of Sugar Beets Genetically Engineered to Be Tolerant to the Herbicide Glyphosate To whom it may concern: These comments are...
December 6, 2010
Institute of Medicine Essential Health Benefits BIO Comments 1. What is your interpretation of the word “essential” in the context of an essential benefit package? “Essential” in the context of an essential benefit...
December 3, 2010
Re: Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program [CMS-1345-NC] Dear Administrator Berwick: The Biotechnology Industry Organization (BIO) is pleased to submit the...
December 1, 2010
Dear Honorable Sander Levin and Honorable Dave Camp, We applaud your ongoing leadership on strengthening U.S. manufacturing and reducing our reliance on imported products. The recently released draft bill, Domestic Manufacturing and Energy Jobs...
November 22, 2010
RE: Participation of Malaysia in the Trans-Pacific Partnership Trade Negotiations Dear Ms. Blue: The Biotechnology Industry Organization (BIO) is pleased to have the opportunity to comment on the proposed accession of Malaysia to the Trans...
November 19, 2010
Re: Comments on Dispute Resolution Dear Ms. Taylor: The Biotechnology Industry Organization (“BIO”) appreciates this opportunity to respond to HRSA’s September 20, 2010 advance notice of proposed rulemaking and request for...
November 19, 2010
Re: Comments on the Civil Monetary Penalties Dear Mr. Lang: The Biotechnology Industry Organization (BIO) appreciates this opportunity to respond to HRSA’s September 20, 2010 advance notice of proposed rulemaking and request for comments...
November 19, 2010
Re: Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System, 75 Fed. Reg. 181, 57261 Washington, D.C., November 19, 2010 Dear Under Secretary Kappos: The Biotechnology Industry...
November 19, 2010
Re: (Docket No. FDA-2010-N-0385) Food Labeling; Labeling of Food Made From AquAdvantage Salmon Dear Sir/Madam: The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide input on the application of the food labeling...
November 8, 2010
Re: Docket No. FDA-2010-D-0451: Draft Guidance for Industry on Suicidality: ProspectiveAssessment of Occurrence in Clinical Trials Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for...
November 1, 2010
Re: Docket No. Docket No. FDA-2010-N-0506, Request for Comments on the Food and Drug Administration Fiscal Year 2011-2015 Strategic Priorities Document Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
November 1, 2010
Re: Docket No. FDA-2010-D-0246: Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
October 29, 2010
No. 2010-1406 UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT ——————————— THE ASSOCIATION FOR MOLECULAR PATHOLOGY, THE AMERICAN COLLEGE OF MEDICAL GENETICS, THE AMERICAN...
October 29, 2010
RE: Request for comments and information at Step 3 on the proposed draft Recommendations for the Labeling of Foods and Food Ingredients obtained through Certain Techniques of Genetic Modification/Genetic Engineering (ALINORM 10/33/22 paras.159 to...
October 29, 2010
Re: Docket No. FDA–2010–N–0437, Development and Distribution of Patient Medication Information for Prescription Drugs Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA...
October 29, 2010
BIO submitted comments on FDA’s "Development and Distribution of Patient Medication Information for Prescription Drugs." The comments elaborate on previous comments and further address the questions raised at the September 27-28...
October 24, 2010
Dear Governor Fortuño: In what is currently one of the worst economic recessions to be experienced in our lifetime, the life sciences industry, and the biotechnology sector in particular, is defying all odds – Biotechnology companies...