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BIO Submits Comments Re: CY 2016 Medicare Physician Fee Schedule Proposed Rule

Sep 8 2015
The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed rule entitled Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 20161 (the “Proposed Rule”).

Multi-state food and ag organization letter to the White House on agriculture innovation and trade issues

Sep 4 2015
Now more than ever, American agriculture needs your continued engagement with China’s President Xi Jinping on agricultural innovation and trade. The undersigned organizations embrace innovation to continue reliably supplying our valued customers in China and in other markets around the world. Sustainably meeting the challenges of global food security is important not only for China, but for all countries, and requires access to innovation and to markets. For these reasons, we ask you to make securing positive action on pending biotechnology issues a priority when you meet with President Xi in Washington, D.C. later this month. 

BIO Submits Comments Re: CY 2016 Medicare Outpatient Prospective Payment System (OPPS) Proposed Rule

Sep 2 2015
Dear Acting Administrator Slavitt: The Biotechnology Industry Organization (BIO) is pleased to comment on the Centers for Medicare & Medicaid Services (CMS) proposed rule regarding payment policies under the calendar year (CY) 2016 hospital outpatient prospective payment system (OPPS), published in the Federal Register on July 8, 2015 (the “Proposed Rule”).  

BIO Submits Comments on Draft EMA Guideline on Gene Therapy

Aug 30 2015
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products.”

BIO Submits Comments Re: ESRD PPS Proposed Rule

Aug 25 2015
The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed rule entitled Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program(the “Proposed Rule”).    

BIO Submits Comments Re: CMP & Ceiling Price Proposed Rule

Aug 25 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit the following comments to the Department of Health and Human Services (HHS) in response to the proposed rule issued by the Health Resources and Services Administration (HRSA) on June 17, 2015, entitled 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation [RIN-0906-AA89] (the “Proposed Rule”).  

BIO Submits Comments Re: Medicaid MCO Proposed Rule

Aug 25 2015
The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed rule entitled Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules (the "Proposed Rule").   

BIO Submits Comments Re: ASCO Value Framework

Aug 25 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback on the American Society of Clinical Oncology’s (ASCO’s) Value Framework released on June 22, 2015.  

BIO Submits Comments on Patient Preference Information

Aug 16 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry, FDA Staff and Other Stakeholders entitled “Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.”

BIO Submits Comments on Male-Mediated Developmental Risk

Aug 8 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.