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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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format.  BIO welcomes this Draft Guidance to ensure appropriate consistency in the format and content of product labeling for all prescription drug products approved by the Agency.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

BIO Submits Comments to CMS Regarding the CY 2011 Physician Fee Schedule Proposed Rule

Oct 1 2014
The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services' (CMS) proposed rule regarding payment policies under the physician fee schedule (PFS) and other revisions to Part B for calendar year (CY) 2011 (the "Proposed Rule").

Estimated GHG Increase from Obama Administration Inaction on the 2014 RFS

Sep 23 2014
Inaction on the 2014 RFS regulatory rule will lead to increased GHG emissions of 21 million metric tons CO2 equivalent. The increased GHG emissions are equal to putting an additional 4.4 million cars on the road or opening 5.5 new coal-fired power plants. The “blend wall” should not be a consideration for setting the RFS, because the United States is using more transportation fuel in 2014 than previously projected.

BIO Submits Comments to WHO on INN Biological Qualifier for Biosimilars

Sep 18 2014
The Biotechnology Industry Organization (BIO) thanks the World Health Organization (WHO) for the opportunity to submit comments on “INN Working Doc. 14.342 - Biological Qualifier: An INN Proposal.” BIO commends WHO on the release of this proposed policy, which aims to create a consistent, global system for ensuring that all biological products are identified by a unique Biologic Qualifier (BQ).

BIO Submits Comments on Correcting Independent 3rd Party Misinformation Via Social Media

Sep 14 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 Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.”