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BIO Comments on FDA's Reference Product Exclusivity Draft Guidance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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Internet Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.”

BIO Submits Comments on Presenting Benefit and Risk Information Via Social Media Platforms with Character Space Limitations

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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Internet/Social Media Platforms With Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”

BIO Submits Comments to HHS Regarding the Proposed Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) Charter

Sep 2 2014
The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the proposed changes to the Medicare Evidence Development and Coverage Advisory Committee’s (MEDCAC’s) charter, which were released on August 1, 2014.

BIO Submits Comments to CMS Regarding the End-Stage Renal Disease Prospective Payment System Proposed Rule

Sep 2 2014
The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS’s) proposed rule regarding payment policies under the End-Stage Renal Disease Prospective Payment published in the Federal Register on July 11, 2014 (the “Proposed Rule”).

BIO Submits Comments to CMS Regarding the CY 2015 Physician Fee Schedule Proposed Rule

Sep 2 2014
The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS’s) proposed rule regarding payment policies under the physician fee schedule (PFS), clinical laboratory fee schedule, and other revisions to Part B for calendar year (CY) 2015 (the “Proposed Rule”).

BIO Submits Comments to CMS Regarding the CY 2015 Hospital Outpatient Prospective Payment System Proposed Rule

Sep 2 2014
The Biotechnology Industry Organization (BIO) is pleased to comment on the Centers for Medicare & Medicaid Services (CMS) proposed rule regarding payment policies under the calendar year (CY) 2015 hospital outpatient prospective payment system (OPPS), published in the Federal Register on July 14, 2014 (the "Proposed Rule").