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BIO Comment on EPA’s Renewables Enhancement and Growth Support (REGS) Proposed Rule

BIO supports EPA’s ongoing efforts to improve the efficiency and effectiveness of the federal Renewable Fuel Standard (“RFS”) program, which was created by Congress, with bipartisan support, in statutory provisions that President George W. Bush signed into law as part of the Energy Policy Act of 2005 and Energy Independence and Security Act of 2007.

BIO Comment on EPA's Proposed Denial of Petitions for Rulemaking to Change the RFS Point of Obligation

BIO is supportive of EPA’s proposal. In BIO’s view, granting the petitions in question would add unnecessary regulatory complexity and uncertainty to the Renewable Fuel Standard ("RFS") program, jeopardize U.S. economic and job growth, and would fail to further the statutory requirements and goals that Congress directed EPA to enforce and pursue when Congress created the program.

BIO Submits Brief of Amicus Curiae in Sandoz Inc. v. Amgen Manufacutring Inc. and Amgen Manufacturing Ltd v. Sandoz Inc. (Supreme Court of the United States)

BIO Submits Brief of Amicus Curiae in Sandoz Inc. v. Amgen Inc. v. Sandoz Inc. (Supreme Court of the United States)  

BIO Congratulates Sonny Perdue, U.S. Agriculture Secretary

Washington, D.C. (April 24, 2017) – The Biotechnology Innovation Organization (BIO) congratulates Sonny Perdue on his confirmation to be U.S. Agriculture Secretary.  In bipartisan fashion, the Senate overwhelmingly approved Perdue by a vote of 87 to 11.

BIO Selects San Diego Industry Leaders For 2017 Convention Steering Committee

The Biotechnology Innovation Organization (BIO) has announced the steering committee for its upcoming BIO 2017 International Convention, which will be held in downtown San Diego from June 19 to 22. 

BIO Announces Educational Sessions for 2017 BIO World Congress on Industrial Biotechnology

Panels feature international speakers from renewable chemical and consumer product companies.

Combo Products: BIO Comments on FDA Draft Guidance, How to Prepare a Pre-Request for Designation (Pre-RFD)

Re: Docket No. FDA–2017-D-0040: FDA Draft Guidance, How to Prepare a Pre-Request for Designation (Pre-RFD) ...

Combo Products: BIO Comments on Topics That May be Considered by the Food and Drug Administration Combination Product Policy Council

Re: Docket No. FDA–2017-N-0086: Suggestions, Recommendations and Comments for Topics That May be Considered by the Food and Drug Administration Combination Product Policy Council ...

BIO Submits Comments Re: ICER Proposed Value Assessment Framework Revisions

BIO submitted comments on the Institute for Clinical and Economic Review (ICER)'s call for proposed improvements to its Value Assessment Framework. While some of the proposed revisions have the potential to make progress toward aligning the Framework with the principles of individualized patient care and holistic value assessment, ICER must provide additional details with regard to how these proposed revisions will be operationalized before stakeholders can assess whether the revisions will meaningfully address critical gaps in the Framework.

BIO Statement on MedPAC Vote

Washington, DC (April 6, 2017) – The Biotechnology Innovation Organization (BIO) issued the following statement regarding today's Medicare Payment Advisory Commission (MedPAC) vote: