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BIO Submits Comments to the Office of Science Technology and Policy (OSTP) on the Bioeconomy

Oct 22 2019
The Biotechnology Innovation Organization (BIO) has submitted comments to the Office of Science Technology and Policy (OSTP) on the bioeconomy, explaining the critical role America’s biotechnology industry plays in feeding, fueling, and healing the world. The comments were recently highlighted by Tom DiLenge, president of BIO’s Advocacy, Law & Public Policy Division, during The White House Summit on America’s Bioeconomy, which included leaders from industry, academia, and the government.

BIO Submits Comments re: CY 2020 Medicare Physician Fee Schedule Proposed Rule

Oct 21 2019
BIO offers comments on the following areas in the proposed rule, with an emphasis on ensuring that Medicare beneficiaries have access to the full range of items and services necessary to their health: • BIO appreciates the opportunity to comment on the agency’s future consideration of bundled payments under the PFS but urges CMS to prioritize patient access to appropriate therapies and to weigh the results of other demonstrations underway rather than attempting to swiftly implement bundled payments. • BIO supports the proposal to retain more granular payments for Evaluation and Management (E/M) services, which we think will support access to appropriate care for the sickest patients. • BIO appreciates the efforts CMS is making to treat patients with opioid addiction and offers comments about the agency’s proposals in this area, again with an emphasis on ensuring patient access to appropriate care.

BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule

Oct 21 2019
On September 27, BIO submitted final comments in response to the CY 2020 Outpatient Prospective Payment System Proposed Rule. BIO members are eager to improve health care through the discovery and advancement of new therapies and thus are supportive of appropriate reimbursement in our health care system both to ensure that beneficiaries have proper access to care and to encourage investment in innovation. BIO has evaluated each of CMS's proposals to ensure that they support continued access to crucial treatments and therapies in the hospital outpatient setting for Medicare beneficiaries. We briefly describe our feedback on these proposals in more detail in the balance of the letter. 

Pediatrics: BIO Comments on FDA Draft Guidance on Rare Pediatric Priority Review Vouchers

Oct 2 2019

September 30, 2019

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ICH: BIO Comments on ICH E8(R1) General Considerations for Clinical Studies

Sep 30 2019

September 30, 2019

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ICH: BIO Comments on FDA Draft Guidance ICH E19 Optimisation of Safety Data Collection

Sep 27 2019

September 25, 2019

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ICH: BIO Submits Comments on FDA Draft Guidance ICH M10 Bioanalytical Method Validation

Sep 25 2019

September 25, 2019

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BIO Submits Comments on FDA : New Drug Regulatory Program Modernization: Improving Approval Package Documentation and Communication

Aug 26 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the New Drug Regulatory Modernization: Improving Approval Package Documentation and Communication.

Clinical Trials: BIO Comments on FDA Draft Guidance Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs

Aug 6 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs.

Biosimilars: BIO Comments on FDA Draft Guidance : Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations

Jul 19 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.