The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the U.S. Food and Drug Administration (FDA) on the draft environmental assessment (EA)1 and preliminary finding of no significant impact (FONSI) regarding the proposed field trial of the OX513A strain of Aedes aegypti (Ae. aegypti) developed by Oxitec.

Dear Dr. Taichman: The Biotechnology Innovation Organization (BIO) is pleased to offer the following comments on Sharing Clinical Trial Data: A proposal from the International Committee of Medical Journal Editors (“ICMJE”) (“the Proposal”). 1 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. General Comments BIO member companies are committed to improving human health through the development of innovative therapies. We strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing our clinical trial data can help to advance such research, while reinforcing public confidence in the safety and efficacy of our medicines. As such, we share the underlying goals of ICMJE in setting forth a policy to “increase confidence and trust in the conclusions drawn from clinical trials,” “enable the independent confirmation of results,” and “foster the development and testing of new hypotheses.”2 Even though most BIO member companies are small, prerevenue enterprises that operate with limited resources, and evaluation of requests for data may divert resources from their core mission of developing innovative therapies, BIO members recognize the value of supporting qualified external medical and scientific research via data sharing... 

The Biotechnology Innovation Organization (BIO) is pleased to submit these comments to FDA in response to FDA’s request for information on the use of the term “natural” on food labeling (docket no. FDA-2014-N-1207). BIO is the world's largest biotechnology trade association, representing companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than thirty other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products.

The Biotechnology Innovation Organization appreciates this opportunity to submit comments on the Centers for Medicare and Medicaid Services’ proposed rule entitled Medicare Program; Part B Drug Payment Model...

The Biotechnology Innovation Organization (BIO) would like to take the opportunity to follow-up and expand on the feedback we originally submitted to the Institute for Clinical and Economic Review (ICER) in October 2015 on the ICER Value Framework (the “Framework”).