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BIO Submits Comments Re: FDA Rare Diseases Guidance

Oct 22 2015
RE: Docket No. FDA–2015–D–2818 Draft Guidance for Industry: Rare Diseases—Common Issues in Drug Development   Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry, entitled “Rare Diseases: Common Issues in Drug Development” (Draft Guidance).   BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.

BIO, ABA Members Weigh in on Coordinated Framework

Oct 21 2015
We are writing to express our appreciation for the guidance and opportunity for input provided by the Request for Information (RFI) on the White House initiative to review and assess the Coordinated Framework (CF). We strongly support this one-year initiative and its objectives: to ensure public confidence in the regulatory system and prevent unnecessary barriers to future innovation and competitiveness, while continuing to protect health and the environment.

BIO Submits Comments on Draft Testicular Toxicity Guidance

Oct 14 2015
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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Testicular Toxicity: Evaluation During Drug Development

BIO Submits Comments to Steve Pearson re: ICER Value Framework

Oct 14 2015
Steven D. Pearson, MD, MSc, FRCP President, Institute for Clinical and Economic Review One State Street Suite 1050 Boston, MA 02109 USA   BY ELECTRONIC DELIVERY   RE: Institute for Clinical and Economic Review (ICER) Value Framework   Dear Dr. Pearson:   On behalf of the Biotechnology Industry Organization (BIO), I would like to submit the following feedback with respect to ICER’s Value Framework, presented on September 15, 2015. BIO advocates on behalf of biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

BIO Submits Comments Re: CMS HCPCS Public Meeting

Sep 28 2015
RE: Centers for Medicare and Medicaid Services Healthcare Common Procedure Coding System Public Meeting, May 7, 2015   Dear Ms. Carver:   The Biotechnology Industry Organization (BIO) is pleased to provide comments in response to the May 7 Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Public Meeting Agenda for Drugs, Biologicals and Radiopharmaceuticals (“Public Meeting Agenda”).

U.S. Biotech Crops Alliance letter to the White House on agriculture innovation and trade issues

Sep 10 2015
The U.S. Biotech Crops Alliance greatly appreciates your efforts to elevate the U.S.- China dialogue on agricultural innovation. Your engagement with President Xi Jinping at the 2014 APEC Summit established a strong foundation on which to build a robust, mutually beneficial, long-term dialogue on cooperation as it relates to agricultural innovation, including global food security, climate unpredictability and rural economic growth. In this regard, we ask that practical, trade facilitating measures to ensure increased Chinese access to the products of U.S. agriculture be a priority for your upcoming meeting with President Xi.  

BIO Submits Comments Re: CY 2016 Medicare Physician Fee Schedule Proposed Rule

Sep 8 2015
The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed rule entitled Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 20161 (the “Proposed Rule”).

Multi-state food and ag organization letter to the White House on agriculture innovation and trade issues

Sep 4 2015
Now more than ever, American agriculture needs your continued engagement with China’s President Xi Jinping on agricultural innovation and trade. The undersigned organizations embrace innovation to continue reliably supplying our valued customers in China and in other markets around the world. Sustainably meeting the challenges of global food security is important not only for China, but for all countries, and requires access to innovation and to markets. For these reasons, we ask you to make securing positive action on pending biotechnology issues a priority when you meet with President Xi in Washington, D.C. later this month. 

BIO Submits Comments Re: CY 2016 Medicare Outpatient Prospective Payment System (OPPS) Proposed Rule

Sep 2 2015
Dear Acting Administrator Slavitt: The Biotechnology Industry Organization (BIO) is pleased to comment on the Centers for Medicare & Medicaid Services (CMS) proposed rule regarding payment policies under the calendar year (CY) 2016 hospital outpatient prospective payment system (OPPS), published in the Federal Register on July 8, 2015 (the “Proposed Rule”).  

BIO Submits Comments on Draft EMA Guideline on Gene Therapy

Aug 30 2015
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products.”