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Electronic Health Record Data: BIO Comments on FDA Draft Guidance Use of Electronic Health Record Data in Clinical Investigations

Electronic health record (EHR) data and “real world evidence” generated from the post-marketing clinical use of medicines can provide valuable information regarding the use, benefits, or risks of therapies. BIO applauds FDA for taking steps to provide greater clarity around the use of EHR data in clinical assessments of safety and effectiveness in regulatory submissions.

SPA: BIO Comments on Special Protocol Assessment; Draft Guidance for Industry

BIO is supportive of FDA’s efforts to clarify the special protocol assessment (SPA) process for sponsors through the updated draft Special Protocol Assessment guidance, which provides helpful clarification on which protocols are eligible for SPA, as well as other updates and details.

Compounding: BIO Comments on FDA Draft Guidance Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act

BIO applauds the issuance by the FDA of this Draft Guidance as it recognizes the importance of the prescription requirement under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). BIO recognizes that access to medically-needed compounded medicines is highly important; but access cannot and should not come at the expense of product quality and patient safety.

BIO Comments on Renewable Fuel Standards for 2017

BIO urges EPA to get the RFS back on track with a commitment to stable implementation of the program that tracks statutory requirements. In particular, we urge EPA to account more appropriately for the availability of advanced and other biofuels to meet statutory volume requirements, and to make significant changes to EPA’s proposed reductions in volume requirements for advanced biofuel, cellulosic biofuel, and total renewable fuel.

Combination Products: BIO Comments on FDA Draft Guidance Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development”

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Biosimilars: BIO Comments on FDA Draft Guidance Labeling for Biosimilar Products

Re: Draft Guidance for Industry: Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643 (April 4, 2016)) ...

CMC: BIO Submits Comments on FDA Draft Guidance Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

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

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

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)

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.