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BIO Submits Comments on ClinicalTrials.gov Expansion

Mar 22 2015
The Biotechnology Industry Organization (BIO) thanks the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) for the opportunity to submit comments on the Notice of Proposed Rulemaking (NPRM) entitled Clinical Trials Registration and Results Submission.

BIO Testimony Regarding Hawaii SB 717: “AN ACT TO REPEAL THE REQUIREMENT THAT GASOLINE FOR MOTOR VEHICLES IN THE STATE INCLUDE 10% ETHANOL”

Mar 16 2015
Chairman Lee, Vice Chairman Lowen, and Members of the Committee, the Biotechnology Industry Organization (“BIO”) appreciates this opportunity to provide comments on SB 717, legislation repealing the requirement that gasoline for motor vehicles in the state include 10% ethanol. This proposal is of significant concern to BIO and its members in the State of Hawaii and throughout the country.  

BIO Comments on the Draft National IPR Policy

Mar 6 2015
BIO commends the Government of India for recognizing the critical role that intellectual property plays in innovation and for initiating a review of its policies regarding intellectual property.

BIO Response to the Alexander/Burr report

Feb 23 2015
The Biotechnology Industry Organization (BIO) thanks you for the opportunity to provide our initial thoughts on your report Innovation for Healthier Americans. 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 Submits Comments on Minimal Manipulation

Feb 22 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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry and FDA Staff entitled “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products” (HCT/P).

BIO Comments to the California Air Resources Board On the Low Carbon Fuel Standard

Feb 19 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments to the California Air Resources Board (CARB) on the Low Carbon Fuel Standard (LCFS) readoption plan (the readoption plan, or the plan)

BIO Submits Comments on Rare Pediatric Disease Priority Review Vouchers

Feb 12 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 entitled “Rare Pediatric Disease Priority Review Vouchers.”

BIO 2015 Special 301 Submission

Feb 9 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to participate in the Special 301 process and is hopeful that our contribution will assist the United States Trade Representative’s (USTR) efforts in preserving strong intellectual property protections for United States’ companies internationally. BIO appreciates the opportunity to comment on 2015 Special 301 Review: Identification of Countries Under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing.

BIO Submits Comments on Pediatrics Clinical Pharmacology

Feb 8 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 entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.”

BIO Comments Submitted to FDA on Regulation of LDTs

Feb 5 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on two draft guidance release on October 3, 2014, entitled Framework for Regulatory Oversight of Laboratory Developed Tests (the "Framework Guidance") and FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) (the "Notification Guidance) (Collectively the "LDT Guidance").