Combination Products: BIO Comments on FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products
April 17, 2020
April 12, 2020
Re: Docket No. FDA–2019-D-5585: FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.
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.
BIO commends FDA for the development of the Draft Guidance on Bridging for Drug-Device and Biologic-Device Combination Products. Developers continue to face challenges with combination product development and review and guidance such as this provides important information for developers and helps alleviate challenges. BIO believes that the Draft Guidance presents a reasonable approach to bridging for combination products. The Draft Guidance appropriately provides a framework for sponsors to use in assessing what data are required for bridging and BIO believes that the approach taken in this Draft Guidance is more appropriate and flexible than outlining specific requirements for every bridging study. BIO has outlined in this letter suggestions for FDA’s consideration as the FDA is finalizing the Guidance.
BIO appreciates the opportunity to submit comments regarding FDA’s Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products. We would be pleased to provide further input or clarification of our comments, as needed.
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.
The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.
April 12, 2020
Re: Docket No. FDA–2019-D-5585: FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.
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.
BIO commends FDA for the development of the Draft Guidance on Bridging for Drug-Device and Biologic-Device Combination Products. Developers continue to face challenges with combination product development and review and guidance such as this provides important information for developers and helps alleviate challenges. BIO believes that the Draft Guidance presents a reasonable approach to bridging for combination products. The Draft Guidance appropriately provides a framework for sponsors to use in assessing what data are required for bridging and BIO believes that the approach taken in this Draft Guidance is more appropriate and flexible than outlining specific requirements for every bridging study. BIO has outlined in this letter suggestions for FDA’s consideration as the FDA is finalizing the Guidance.
BIO appreciates the opportunity to submit comments regarding FDA’s Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products. We would be pleased to provide further input or clarification of our comments, as needed.