id,filing_uuid,filing_type,registrant_name,registrant_id,client_name,filing_year,filing_period,issue_code,specific_issues,government_entities,income_amount,expense_amount,is_no_activity,is_termination,received_date 1683451,a4863211-ec4e-4e0d-b10b-4df67d004ad2,Q1,BIOTECHNOLOGY INNOVATION ORGANIZATION,6245,BIOTECHNOLOGY INNOVATION ORGANIZATION,2015,first_quarter,HCR,"Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues","Agriculture, Dept of (USDA),Centers For Medicare and Medicaid Services (CMS),Food & Drug Administration (FDA),Health Resources & Services Administration (HRSA),HOUSE OF REPRESENTATIVES,Natl Institutes of Health (NIH),Patent & Trademark Office (PTO),Securities & Exchange Commission (SEC),SENATE,Treasury, Dept of,U.S. Trade Representative (USTR),White House Office",,2010000,0,0,2015-04-20T17:59:01.790000-04:00