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 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,…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.
BIO and its member companies are committed to meeting the requirements of the Drug Supply Chain Security Act (DSCSA)…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.
BIO supports enhanced regulatory guidance on considerations for approval of generic and follow-on…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Pediatric Rare Diseases – A Collaborative Approach for Drug Development Using Gaucher Disease as a Model.
BIO appreciates the FDA’s intended goal with the guidance – to reduce the total number of children needed for…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.
This draft guidance provides important information on the expedited programs available to sponsors of regenerative medicine therapies…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.
BIO welcomes the FDA’s efforts to provide clear, concise guidance on the regulatory and scientific framework for product developers of…
BIO submitted comments after the Food and Drug Administration’s (FDA) public hearings on Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input.
BIO commends the FDA’s efforts to facilitate the use of patient experience data (PED) for medical product…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.
The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) provide new…
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products.
BIO supports the FDA’s efforts to update and replace the 1997 version of this guidance, and suggests the FDA…