Close
Leave blank for all. Otherwise, the first selected term will be the default instead of "Any".

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.

BIO Comments on Brazil’s ANVISA Public Consultation #65, Regulating Clinical Trials (submitted September 9 2014)

Oct 14 2014
The Biotechnology Industry Organization (BIO) welcomes the opportunity to provide comments to Public Consultation #65 published by the Board of Directors of the National Health Surveillance Agency on August 4, 2014 which proposes a new regulation defining the procedures and requirements for conducting clinical trials involving drugs in Brazil.

BIO Comments on Brazilian Ministry of Health Public Consultation #8, Regulating Public-Private Productive Development Partnerships (PDPs) (submitted September 5 2014)

Oct 14 2014
The Biotechnology Industry Organization (BIO) welcomes the opportunity to provide comments to Public Consultation #8 published by the Brazilian Ministry of Health on August 14, 2014 which proposes a new regulation defining the guidelines and criteria for the submission, formation, monitoring and evaluation of PDP (Public-Private Productive Development Partnerships) projects.

BIO Comments on Colombia’s Proposed Biologics and Biosimilars Regulations (submitted July 25 2014)

Oct 14 2014
The Biotechnology Industry Organization (BIO) appreciates this fifth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin.

BIO Comments on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format

Oct 13 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 Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format.  BIO welcomes this Draft Guidance to ensure appropriate consistency in the format and content of product labeling for all prescription drug products approved by the Agency.  

BIO Comments on FDA's Reference Product Exclusivity Draft Guidance

Oct 5 2014