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BIO Submits Comments on Patient Engagement during Medical Product Development

Dec 3 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on potential strategies to enhance patient participation in drug and biologic development discussions.

BIO Submits Comments to CDISC on SEND Implementation Guide

Dec 2 2014
The Biotechnology Industry Organization (BIO) thanks the Clinical Data Interchange Standards Consortium (CDSIC) for the opportunity to submit comments on its Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) Version 3.1.

BIO Sends Letter to EPA Administrator Gina McCarthy RE: RFS Petition Process Input

Dec 1 2014
On March 31, 2014, the Biotechnology Industry Organization (“BIO”) sends letter to the U.S. Environmental Protection Agency’s (“EPA”) expressing concerns with the Agency's decision to halt its petition process for new renewable fuel pathways.

BIO Submits Comments on Proposed Rule Revocation of Duplicative Requirements in BLAs

Nov 19 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the proposed rule “Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications.”

BIO Submits Comments Viral Shedding Draft Guidance

Nov 18 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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products.” BIO greatly appreciates the Agency’s work to develop this guidance and notes our support expressed previously in comments on the Draft Guidance for Industry on Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products.

BIO Submits Comments to PCORI's Proposal for Peer Review of Primary Research and Public Release of Research Findings

Nov 14 2014
The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Patient-Centered Outcomes Research Institute's (PCORI's) Proposal for Peer Review of Primary Research and Public Release of Research Findings (the "Draft Proposal"). 

BIO Submits Comments to PCORI's Proposal for Peer Review of Primary Research and Public Release of Research Findings

Nov 14 2014
The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Patient-Centered Outcomes Research Institute's (PCORI's) Proposal for Peer Review of Primary Research and Public Release of Research Findings (the "Draft Proposal"). 

BIO Submits Comments on Advancing the Use of Biomarkers and Pharmacogenomics

Nov 11 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on “Advancing the Use of Biomarkers and Pharmacogenomics; Notice of Public Meeting; Request for Comments.” BIO appreciates the Agency’s commitment to advancing biomarker science and agrees that biomarkers offer the potential to realize much greater efficiency in, and a more personalized approach to, drug development.

BIO and the Advanced Ethanol Council Send Letter to White House RE: Proposed 2014 RFS Volumetric Blending Requirements

Oct 29 2014
RE: Proposed 2014 RFS Volumetric Blending Requirements On behalf of the more than 35 advanced biofuel companies listed below, we are writing to express our concern about a recently release drafted of the proposed 2014 RFS volumetric blending requirement. While the official proposed rule has not been released, it is clear that a number of key issues are under consideration at the present time.

BIO Submits Comments on Informed Consent Guidance

Oct 26 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.” BIO shares FDA’s commitment to enhancing communication with, and thereby the protection of, human research subjects.