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Letters, Testimony & Comments

BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.

Featured Letters, Testimony, & Comments
BIO Letter to HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
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CSBA Letter to Congressional Leadership on…
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BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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BIO AFBF GE Salmon Labeling Provision Letter
September 15, 2016
The Biotechnology Innovation Organization along with the American Farm Bureau Federation sent a letter to the House of Representatives and Senate Appropriations Committees urging the Committees to oppose any provision related to bioengineered food…
BIO Submits Comments Re: ICER Value Framework
September 13, 2016
BIO submitted comments on the Institute for Clinical and Economic Review (ICER) Value Assessment Framework. Throughout the attached letter, BIO addresses issues it has raised previously with the Framework as well as responds specifically to the four…
Biosimilars: BIO Comments on FDA Draft Guidance Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009
August 30, 2016
Re: Draft Guidance for Industry: Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (Docket No. FDA-2015-D-4750 (March 14, 2016))   The Biotechnology Innovation…
BIO Comments on Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule
August 8, 2016
BIO submitted comments on the Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule, which focused on several proposals related to, among other things, CMS’s review of New Technology Add-on Applications, the Hospital Value…
Electronic Health Record Data: BIO Comments on FDA Draft Guidance Use of Electronic Health Record Data in Clinical Investigations
July 19, 2016
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…
SPA: BIO Comments on Special Protocol Assessment; Draft Guidance for Industry
July 19, 2016
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…
Compounding: BIO Comments on FDA Draft Guidance Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act
July 19, 2016
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…
BIO Comments on Renewable Fuel Standards for 2017
July 11, 2016
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…
Combination Products: BIO Comments on FDA Draft Guidance Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development”
June 23, 2016
Re: Docket No. FDA-2015-D-4848: Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development   Dear Sir/Madam:   The Biotechnology Innovation Organization (BIO) thanks the Food…
Biosimilars: BIO Comments on FDA Draft Guidance Labeling for Biosimilar Products
June 23, 2016
Re: Draft Guidance for Industry: Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643 (April 4, 2016))   The Biotechnology Innovation Organization (“BIO”) welcomes the opportunity to submit comments on the Food and Drug…