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BIO Submits Comments Re: CMP & Ceiling Price Proposed Rule

Aug 25 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit the following comments to the Department of Health and Human Services (HHS) in response to the proposed rule issued by the Health Resources and Services Administration (HRSA) on June 17, 2015, entitled 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation [RIN-0906-AA89] (the “Proposed Rule”).  

BIO Submits Comments Re: Medicaid MCO Proposed Rule

Aug 25 2015
The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed rule entitled Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules (the "Proposed Rule").   

BIO Submits Comments Re: ASCO Value Framework

Aug 25 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback on the American Society of Clinical Oncology’s (ASCO’s) Value Framework released on June 22, 2015.  

BIO Submits Comments on Patient Preference Information

Aug 16 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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry, FDA Staff and Other Stakeholders entitled “Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.”

BIO Submits Comments on Male-Mediated Developmental Risk

Aug 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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.

BIO Comments on Established Conditions Reportable CMC Changes

Jul 30 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).

BIO Comments on Established Conditions Reportable CMC Changes

Jul 30 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).

BIO Submits Comments to U.S. Environmental Protection Agency’s Proposed Rule Titled “Renewable Fuel Standard Program: Standards for 2014, 2015, and 2016 and Biomass Based Diesel Volume for 2017

Jul 27 2015
The Biotechnology Industry Organization (“BIO”) is pleased to have the opportunity today to comment on the U.S. Environmental Protection Agency’s (“EPA’s”) recently published proposed rule titled “Renewable Fuel Standard Program: Standards for 2014, 2015, and 2016 and Biomass Based Diesel Volume for 2017.”    

Seventy Nine House Members Express Concern with H.R. 9, The Innovation Act

Jul 27 2015
A coalition of 79 house members have requested significant improvement upon language within H.R. 9, the Innovation Act, in order to preserve the effectiveness of Hatch-Waxman and the Biologics Price Competition and Innovation Act.

BIO Presents Statement at FDA PDUFA 6 Meeting

Jul 14 2015
On behalf of the Biotechnology Industry Organization (BIO), thank you for the opportunity to provide our comments on the success of the PDUFA program and recommendations to enhance the program through the user fee reauthorization process.