Close

Clinical Trials: BIO Comments on FDA Promoting the Use of Complex Innovative Designs in Clinical Trials

Mar 23 2018

Re: Docket No. FDA-2018-N-0049: Promoting the Use of Complex Innovative Designs in Clinical Trials

...

CMC: BIO Comments on FDA Draft Guidance Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products

Mar 22 2018

Re: Docket No. FDA-1995-D-0288: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry

...

BIO Written Testimony for House Ways and Means Hearing on Expired Tax Provisions

Mar 14 2018
BIO supports a seamless multi-year extension for the Second Generation Biofuel Producer Tax Credit; Special Depreciation Allowance for Second Generation Biofuel Plant Property; Biodiesel and Renewable Diesel Fuels Credit; and the Alternative Fuel Vehicle Refueling Property, which expired at the end of 2017. BIO also supports the extension and expansion of the tax code to include the Qualifying Renewable Chemical Production or Investment Tax Credit and Master Limited Partnerships (MLP) to advanced biofuel and renewable chemicals.

BIO Submits Comments Re: CY 2019 Medicare Advantage and Part D Call Letter

Mar 7 2018
BIO supports CMS’s commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment, particularly for prescription drugs and vaccines. To that end, we provide comments in the following areas: The specialty tier eligibility cost threshold should be increased for 2019 and in future years and the exceptions process expanded to ensure that the specialty tier does not discriminate against vulnerable beneficiaries;  Co-insurance in the Part D non-preferred drug tier can unduly limit access to care for patients with severe and complex diseases;  Increased enforcement of nondiscrimination should be used when evaluating benefit design in the MA and Part D programs;  Access to innovative treatment options for pain and addiction should be prioritized as a part of addressing opioid overutilization in MA Part D plans;  MA and Part D plans should prioritize and increase access to vaccinations for Medicare beneficiaries;  The timeframes and processes for formulary updates should support the inclusion of new therapies;  Drug tier labels should be accurately reflective of the tier’s composition.  The inclusion of prescription drug costs in Medicare advantage uniformity flexibility should provide patient access to the most appropriate treatment;  Additional flexibility in design of maximum out-of-pocket costs should be considered to assist beneficiaries;  The availability of suitable plan offerings should be increased through removal of the meaningful difference requirements;      Additions to the Star Ratings are critical to accurate assessment of patient care quality; and  Efforts to expand coverage for certain subsets of products MA-PD plans should focus across all drugs offered under the Part D program.

Orphan Drugs: BIO Comments on FDA Draft Guidance Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases

Feb 16 2018

Re: Docket No. FDA-2017-D-6380: Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases

...

PFDD: BIO Comments on FDA Public Workshop on Patient-Focused Drug Development: Guidance 1- Collecting Comprehensive and Representative Input

Feb 16 2018

Re: Docket No. FDA–2017-N-5896: Public Workshop: Patient-Focused Drug Development: Guidance 1- Collecting Comprehensive and Representative Input

...

BIO Comments on FDA Draft Guidance Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

Feb 16 2018

Re: Docket ID: FDA-2017-D-6617: Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

...

RMAT: BIO Submits Comments on FDA Draft Guidance Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

Feb 16 2018

Re: Docket No. FDA-2017-D-6159: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

...

Biofuel Advocates' Letter to EPA Administrator Pruitt on 2019 Cellulosic Volumes

Feb 15 2018
As the U.S. EPA begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), a group of trade association advocates encourage the agency to take a renewed look at commercially ready cellulosic biofuels.

BIO Food and Agriculture Section Comments to FDA on Guidance on Consultation Procedures: Foods Derived from New Plant Varieties

Feb 9 2018
February 9, 2017 The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in the Federal Register1 regarding information collection burdens associated with its “Guidance on Consultation Procedures: Foods Derived from New Plant Varieties.”