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Combination Products: BIO Comments on FDA Draft Guidance Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development”

Jun 23 2016
Re: Docket No. FDA-2015-D-4848: Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development ...

Biosimilars: BIO Comments on FDA Draft Guidance Labeling for Biosimilar Products

Jun 23 2016
Re: Draft Guidance for Industry: Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643 (April 4, 2016)) ...

CMC: BIO Submits Comments on FDA Draft Guidance Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

Jun 23 2016

Re: Docket No. FDA-2016-D-0973: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

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Office of the National Coordinator for Health Information Technology; Medicare Access and CHIP Reauthorization Act of 2015; Request for Information (RFI) Regarding Assessing Interoperability for MACRA

Jun 3 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments in response to the Request for Information (RFI) Regarding Assessing Interoperability for MACRA (the “RFI”).1 BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

BIO Letter to Senate Appropriations Leadership on Efforts to Label Foods Produced Through Biotechnology Such As the Genetically Engineered Salmon

May 19 2016
The Biotechnology Innovation Organization (BIO) urges you and all members of the Senate Appropriations Committee to support a national bioengineered food labeling legislative solution, which Senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI) are currently crafting in the Senate Agriculture Committee, and to reject all efforts to establish unique labeling requirements for specific bioengineered food products, such as salmon, during consideration of the Fiscal Year 2017 spending bills.

BIO Submits Comments to FDA's Draft EA and Preliminary FONSI Regarding the Proposed Field Trial of the OX513A Strain of Aedes aegypti (Ae. aegypti)

May 18 2016
The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the U.S. Food and Drug Administration (FDA) on the draft environmental assessment (EA)1 and preliminary finding of no significant impact (FONSI) regarding the proposed field trial of the OX513A strain of Aedes aegypti (Ae. aegypti) developed by Oxitec.

BIO Comments Re: Comments on Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors

May 17 2016

Dear Dr. Taichman:

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BIO Comments on FDA Natural Food Labeling

May 11 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit these comments to FDA in response to FDA’s request for information on the use of the term “natural” on food labeling (docket no. FDA-2014-N-1207). BIO is the world's largest biotechnology trade association, representing companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than thirty other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products.

BIO Submits Comments Re: Medicare Program; Part B Drug Payment Model [CMS-1670-P]

May 9 2016
The Biotechnology Innovation Organization appreciates this opportunity to submit comments on the Centers for Medicare and Medicaid Services’ proposed rule entitled Medicare Program; Part B Drug Payment Model...

Follow-Up on BIO’s Comments in Response to the ICER Value Framework

May 4 2016