BIO Comments on CMS Proposed Methodology for 2013 Star Ratings for Medicare Advantage and Prescription Drug Plans

Jan 20 2012
BIO supports the development and use of appropriate, evidence-based quality measures throughout the healthcare system. Quality measures for adult immunizations help ensure that healthcare providers routinely discuss and offer vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) to their patients, resulting in higher vaccine uptake among adults, better health outcomes, improved population health and cost savings for public and private insurance plans.

Coverage with Evidence Development: BIO's Comments on the Centers for Medicare and Medicaid Services’ (CMS) public solicitation for comments on Coverage with Evidence Development (CED)

Jan 19 2012


Orphan Drugs: BIO Submits Comments on Orphan Drug Regulations

Jan 16 2012


Bar Code Technologies: BIO Comments on FDA's Bar Code Technologies for Drugs and Biological Products; Retrospective Review under Executive Order 13563

Jan 8 2012


Biologics: EMA Concept Paper on the Revision of the Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Active Substance: Non-clinical and Clinical Issues

Dec 30 2011


Drug Shortages: BIO Comments on Center for Drug Evaluation and Research (CDER), Approach to Addressing Drug Shortage; Public Workshop; Request for Comments

Dec 22 2011


Biosimilar User Fees: BIO Testifies at Biosimilar User Fee Public Hearing

Dec 15 2011


Glyphosate Tolerant H7-1 Sugar Beets Request: Environmental Impact

Dec 12 2011
BIO comments in response to the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS or the Agency) Draft Environmental Impact Statement-October 2011, Glyphosate Tolerant H7-1 Sugar Beets Request for Nonregulated Status.

China Compulsory License Proposed Provisions Draw Reaction from BIO

Dec 8 2011
BIO's members appreciate the recognition by the Chinese government that robust patent protections will incentivize an innovative biotechnology sector in China.  However, this can only be achieved with policies that ensure rare and narrow use of compulsory licenses only in extreme circumstances.

Transparency Initiative:Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency’s Compliance and Enforcement Data

Dec 1 2011