BIO’s comments on the "Report on the Evidence Regarding Off-Label Indications for Targeted Therapies used in Cancer Treatment" (November 16, 2009)
Read the comments (227 KB PDF)

BIO’s comments in response to the Arizona Health Care Cost Containment System (AHCCCS) Administration’s Notice of Request for Proposal (RFP) on the Specialty Pharmacy Drugs and Services Program (November 10, 2009)
Read the letter (110 KB PDF)

Letter regarding BIO comments on Notice of Request for Extension of Approval of an Information Collection; Introduction of Organisms and Products Altered or Produced Through Genetic Engineering (November 9, 2009)
Read the letter (206 KB PDF)

Letter to Ron Burke regarding BIO comments on CL2009/15-FL, May 2009 Request for Comments: (5) Proposed Draft Recommendations for the Labelling of Foods and Food Ingredients Obtained through Certain Techniques of GM/GE (November 9, 2009)
Read the letter (169 KB PDF)

Food and Drug Administration Transparency Task Force, Public Meeting (November 6, 2009)
BIO comments to the FDA (157 KB PDF)

BIO comments on National Trade Estimate Report on Foreign Trade Barriers (November 3, 2009)
Read the letter (430 KB PDF)

Letter to House and Senate members regarding the R&D tax credit as proposed by H.R. 422 (October 22, 2009)
Read the Letter (2.98 MB PDF)

Increasing Access to Capital for Small Business (October 14, 2009)
Hearing Testimony before the House Small Business Committee
Read the Testimony (88 KB PDF)

Postmarketing Studies and Clinical Trials -- Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act (October 13, 2009)
BIO comments to the FDA (75 KB PDF)

Incorporation of Physical-Chemical Identifiers (PC-ID) into Solid Oral Dosage Form Drug Products for Anticounterfeiting (October 13, 2009)
BIO comments to the FDA (39 KB PDF)

BIO Statement on Draft Report on Gene Patents and Patient Access to Genetic Tests (October 8, 2009)
Read the Statement (125 KB PDF)
Read the Press Release

Letter to Senate Environment and Public Works Chairperson Sen. Barbara Boxer (D-Calif.) on provisions in climate change legislation that could place biofuels under an emissions cap (October 1, 2009)
Read the Letter (42 KB PDF)

International Biotechnology Climate Coalition letter to UNFCCC Parties of the Convention (October 1, 2009)
Read the Letter (153 KB PDF)

BIO Applauds USDA Progress in Implementing Voluntary Labeling for Biobased Products (September 29, 2009)
BIO comments to the FDA (428 KB PDF)

Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submission (September 28, 2009)
BIO comments to the FDA (156 KB PDF)

BIO Comments to EPA Notice of Proposed Rules for the Renewable Fuel Standard (September 25, 2009)
Read the comments (360 KB PDF)

BIO comments on draft Environmental Impact Statement for the administration and implementation of the Biomass Crop Assistance Program (BCAP) (September 24, 2009)
Read the comments (942 KB PDF)

BIO’s final comments as submitted to HHSC Regarding Texas Rider 48 (September 18, 2009)
Read the comments (807 KB PDF)

Letter to Governor Schwarzenegger requesting veto of California Senate Bill 486 (September 16, 2009)
Read the comments (1.24 MB PDF)

Letter regarding Farm & Food Group Supporting FY 2010 Agriculture Research Funding (AFRI Commodity Letter Conference) (September 3, 2009)
Read the letter (18 KB PDF)

Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010 (August 31, 2009)
BIO Comments to CMS regarding Proposed Rule CMS-1413-P
Read the comments (273 KB PDF)

Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates (August 31, 2009)
BIO Comments to CMS regarding Proposed Rule CMS-1414-P
Read the comments (546 KB PDF)

Presenting Risk Information in Prescription Drug and Medical Device Promotion (August 25, 2009)
BIO comments to the FDA (69 KB PDF)

Letter regarding BIO comments on APHIS/PPQ rulemaking (August 10, 2009)
Read the letter (200 KB PDF)

BIO Amicus Brief, In Re Bilski (August 6, 2009)
Read the Amicus Brief (525 KB PDF)
Read the Press Release

Food and Drug Administration Transparency Task Force (August 5, 2009)
BIO comments to the FDA (46 KB PDF)

Letter regarding BIO comments on Interagency Cooperation Under the Endangered Species Act; Proposed Rule; Docket No: FWS-R9-ES-2008-0093 (August 3, 2009)
Read the letter (572 KB PDF)

The Eighth Meeting of the AD-HOC Open-Ended Working Group on Access and Benefit-Sharing (July 31, 2009)
Read the comments (207 KB PDF)

Georgia Department of Community Health’s Re-Issued Notice of Proposed Changes to the Physician’s Injectable Drug List (PIDL) for Medicaid (July 30, 2009)
Read the comments (640 KB PDF)

Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (July 27, 2009)
BIO comments to the FDA (225 KB PDF)

Incentives for Prevention of Healthcare Associated Infections (HAIs) within the Healthcare Reform Proposal (July 21, 2009)
Read the comments (143 KB PDF)

BIO Testifies on Importance of Data Exclusivity and Patent Protection in Pathway for Approval of Biosimilars (July 15, 2009)
Read the Press Release
Read the Testimony (1.55 MB PDF)
Read the Follow-Up Response (235 KB PDF)

Comments in Response to Notice of Proposed Rulemaking: Department of Health and Human Services, 10-144, Chapter 275 - Reporting Requirements for Pharmaceutical Manufacturers and Labelers, and Office of the Attorney General, 26-239, Chapter 111 - Reporting Requirements for Pharmaceutical Manufacturers and Labelers (July 13, 2009)
Read the comments (278 KB PDF)

Advanced Notice of Proposed Rulemaking, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors Rule (July 7, 2009)
BIO comments to the NIH (107 KB PDF)

Letter regarding BIO comments on Docket No. APHIS-2007-0016, "Syngenta Seeds, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered to Produce an Enzyme That Facilitates Ethanol Production" (July 6, 2009)
Read the letter (175 KB PDF)

Draft Guidance, Somatic Cell Therapy for Cardiac Disease (July 1, 2009)
BIO comments to the FDA (69 KB PDF)

NIOSH Hazardous Drugs List (June 30, 2009)
BIO comments to NIOSH (150 KB PDF)

Note for Guidance, Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents Via Human and Veterinary Medicinal Products - Revision 4 (June 30, 2009)
BIO comments to the EMEA (56 KB PDF)

Letter regarding BIO part 340 comments on Docket No. APHIS-2008-0023 (June 29, 2009)
BIO letter to APHIS (265 KB PDF)

BIO Comments to SEC on whether short sale price restrictions or circuit breaker restrictions should be imposed (June 29, 2009)
Read the comments (66 KB PDF)

Draft Guidance, Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma Cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (June 24, 2009)
BIO comments to the FDA (67 KB PDF)

Expansion of the Clinical Trial Registry and Results Data Bank (June 22, 2009)
BIO comments to the NIH (222 KB PDF)

Letter to Chairman Wright regarding AB 136 (Silva) (June 19, 2009)
Read the letter (744 KB PDF)

Letter regarding BIO scoping comments on draft Environmental Impact Statement (EIS) for the Biomass Crop Assistance Program (BCAP) (June 12, 2009)
Read the letter (183 KB PDF)

BIO Testimony at EPA Public Hearing for the Renewable Fuel Standard Rule (June 9, 2009)
Read the letter (60 KB PDF)

Letter to Representatives DeLauro and Kingston and Senators Kohl and Brownback (AFRI Commodity Letter - June 3, 2009)
Read the letter (21 KB PDF)

Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products - Content and Format (June 1, 2009)
BIO comments to the FDA (114 KB PDF)

Letter, United Nations Framework Convention on Climate Change U.S. Department of State (June 1, 2009)
Read the letter (205 PDF)

Letter to USDA, Office of the Secretary regarding BIO’s comments to USDA REE Roadmap 2009-0001 (May 31, 2009)
Read the letter (423 KB PDF)

Letter to Professeur De Schutter, UN Special Rapporteur on the Right to Food (May 29, 2009)
Read the letter (2MB PDF)

USDA’s Role in the Export of Genetically Engineered Agricultural Commodities (May 29, 2009)
Letter to Honorable Tom Vilsack (788 KB PDF)

Letter regarding confirmation as Under Secretary of Research, Education and Economics and Chief Scientist of the USDA (May 29, 2009)
Letter to Honorable Rajiv J. Shah (664 KB PDF)

BIO Comments to PTO on Roundtable on Deferred Examination for Patent Applications (May 29, 2009)
Read the comments (67 KB PDF)

BIO Comments, Draft National Institutes of Health Guidelines for Human Stem Cell Research (May 27, 2009)
Read the comments (68 KB PDF)

Comments, Technical Expert Group on Traditional Knowledge Associated with Genetic Resources ("Traditional Knowledge TEG") under the Convention on Biological Diversity (CBD) (May 22, 2009)
Read the comments (171 KB PDF)

BIO’s Response to the ACCME’s April 22, 2009 Call for Comments (May 15, 2009)
BIO’s comments to the ACCME (293 KB PDF)

BIO Comments to FTC on the Evolving IP Marketplace (May 15, 2009)
Read the comments (138 KB PDF)

BIO Comments to the Secretary's Advisory Committee on Genetics Health, & Society (May 15, 2009)
Read the comments (1.82 MB PDF)

Letter to Dr. John Holdren (OSTP) (May 13, 2009)
Read the letter (1.03 MB PDF)

Letter to Congressional Appropriators Regarding FY2009 Supplemental Appropriations bill (May 5, 2009)
BIO request for funds for pandemic influenza preparedness and intervention, and for biodefense countermeasures.
Read the letter (128 KB PDF)

Letter to David Carlander of EFSA (April 30, 2009)
BIO comments on European Food Safety Authority (EFSA) Call for data for further advice on the implications of animal cloning (SCNT)
Letter to EFSA dated April 30, 2009 (848 KB PDF)
Attachment to the letter (271 KB PDF)

BIO Testimony on the Patent Reform Act of 2009, H.R. 1260, Submitted to the House Committee on the Judiciary (April 30, 2009)
Read the testimony (97 KB PDF)

Consumer Medication Information (CMI) (April 29, 2009)
BIO comments to the FDA
Read the comments

Letter to Minister of Knowledge Economy (MKE) (April 29, 2009)
Read the letter (980 KB PDF)

Amicus Brief in support of Petitioner in IMS Health, Inc. v. Ayotte (April 2009)
BIO’s joint submission with PhRMA to the U.S. Supreme Court (157 MB PDF)

James C. Greenwood, President and Chief Executive Officer, Biotechnology Industry Organization testifies before the House Committee on Science and Technology, Subcommittee on Technology and Innovation (April 23, 2009)
The Role of the SBIR and the STTR Programs in Stimulating Innovation at Small High-Tech Businesses
Read the statement (52 KB PDF)

Rachel K. King, Chief Executive Officer, Glycomimetics, Inc. testifies before the House of Representatives Committee on Small Business (April 22, 2009)
The Importance of Technology in an Economic Recovery
Read the statement (43 KB PDF)

Proposed Regulations to Implement the Low Carbon Fuel Standard (April 22, 2009)
BIO comments to the California Environmental Protection Agency Air Resouces Board
Read the comments (243 KB PDF)

Sustainable Biofuels - A Commonsense Perspective on California's Approach to Biofuels and Global Land Use (April 2009)
White Paper Prepared for BIO by John J. Sheehan (1.99 MB PDF)

BIO Comment Letter to SEC Regarding IFRS Roadmap (April 20, 2009)
BIO comments to the U.S. Securities and Exchange Commission (80 KB PDF)

Nonclinical Evaluation for Anticancer Pharmaceuticals (April 20, 2009)
BIO comments to the FDA (168 KB PDF)

Letter by Michael Wach regarding Maine Comments (April 17, 2009)
Read the letter (34 KB PDF)

Letter to Honorable Kathleen Merrigan (April 17, 2009)
Read the letter (712 KB PDF)

Letter to David Englander of Vermont Fish & Wildlife Department (April 17, 2009)
Read the letter (798 KB PDF)

Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages (April 16, 2009)
BIO comments to the FDA (50 KB PDF)

Draft Guidance, Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (April 16, 2009)
BIO comments to the FDA (139 KB PDF)

Letter to Honorable Tom Vilsack (April 14, 2009)
Read the letter (1 MB PDF)

The Draft Guidance for Industry on Good Importer Practices (April 13, 2009)
BIO comments to the FDA

BIO Comments to the Federal Coordinating Council (FCC) on Comparative Effectiveness Research (April 13, 2009)
Read the comments (131 KB PDF)

BIO Comments to NIH on Expansion of the Clinical Trial Registry and Results Data Bank (April 13, 2009)
BIO comments to NIH (139 KB PDF)

Letter to Honorable Brad Henry (April 10, 2009)
Read the letter (665 KB PDF)

BIO’s Comments on the Provisional Appointments for the Institute of Medicine Committee on Comparative Effectiveness Research Priorities (April 2, 2009)
Read the comments (189 KB PDF)

Letter to Congressional leaders containing principles for energy and climate change legislation (March 30, 2009)
Read the letter (152 KB PDF)

Letter to Honorable Ron Kirk (March 27, 2009)
Read the letter (821 KB PDF)

Sentinel Initiative: Structure, Function, and Scope (March 27, 2009)
BIO comments to the FDA (60 KB PDF)

BIO’s testimony opposing Massachusetts House Bill 109, Senate Bill 17, and Senate Bill 19 (March 26, 2009)
Read the comments (757 KB PDF)

Draft Guidance, Animal Models-Essential Elements to Address Efficacy Under the Animal Rule (March 23, 2009)
BIO comments to the FDA (120 KB PDF)

Comments on the Medicare Program; Medicare Advantage and Prescription Drug Programs MIPPA Drug Formulary and Protected Classes Policies (March 17, 2009)
BIO's comment to the Centers for Medicare & Medicaid Services (141 KB PDF)

Letter to the OMB regarding BIO Comments on Office of Information and Regulatory Affairs -- Docket: E9-4080, Federal Register: February 26, 2009 (Volume 74, Number 37) (March 16, 2009)
Read the letter (922 KB PDF)

SACGHS Roundtable on Genetics and the Future of the Health Care System (March 13, 2009)
BIO’s Statement before the Secretary’s Advisory Committee on Genetics, Health and Society regarding reimbursement of molecular diagnostics.
Read the comments (127 KB PDF)

BIO’s testimony to the Maryland Health and Government Operations Committee opposing House Bill 1155 the Prescription Confidentiality Act (March 12, 2009)
Read the comments (975 KB PDF)

Notice of Public Hearing Concerning Proposed Trans-Pacific Partnership Free Trade Agreement (March 11, 2009)
Read the letter (440 KB PDF)

BIO Encourages Senate Judiciary Committee to Improve Patent Reform Legislation (March 10, 2009)
Read the press release
Read the testimony (64 KB PDF)

BIO’s testimony opposing Connecticut Senate Bill 1050: An Act Concerning the Establishment of an Academic Detailing Program (March 2, 2009)
Read the comments (100 KB PDF)

BIO’s testimony opposing Connecticut Senate Bill 1049: An Act Prohibiting Certain Gifts from Pharmaceutical and Medical Device Companies to Health Care Providers (March 2, 2009)
Read the comments (128 KB PDF)

BIO’s testimony opposing Connecticut Senate Bill 1046: An Act Concerning Restricted Access to Prescription Drug Information (March 2, 2009)
Read the comments (148 KB PDF)

BIO’s testimony to House Health and Operations Committee regarding MD House Bill 574 (February 26, 2009 )
BIO’s testimony on Maryland House Bill 574: Prescription Drugs - Evidence Based Prescriber Education and Outreach Program
Read the comments (200 KB PDF)

Scientific Issues Associated with the Data Required to Register Plant-Incorporated Protectants (February 24, 2009)
BIO comments regarding the February 25-27 meeting of an EPA Scientific Advisory Panel (SAP)
Letter to FIFRA Advisory Panel (840 KB PDF)

Comments on Ethical and Practical Issues in Commercial Support of Continuing Medical Education (CME) (February 23, 2009)
BIO comments to the American Medical Association

Maryland Senate Bill 417 - The Prescription Confidentiality Act (February 20, 2009)
Letter to Chair of the Maryland Senate Finance Committee (620 KB PDF)
BIO’s Testimony to the Maryland Senate Finance Committee (915 KB PDF)

Letter, Identification of Countries involving the Special 301 provisions (February 19, 2009)
Office of the U.S. Trade Representative
Read the letter (187 KB PDF)

Letter to the State Department on Key International Priorities (February 18, 2009)
Letter to Secretary of State Hillary Clinton (829 KB PDF)

BIO’s letter to Montana House Human Services Committee opposing House Bill HB394 (February 9, 2009 )
BIO’s Statement of Opposition to House Bill HB394 (83 KB PDF)

HHS Action Plan to Prevent Healthcare-Associated Infections (February 6, 2009)
BIO comments on the HHS action plan

Letter from BIO to the newly appointed USDA Secretary (January 23, 2009)
BIO letter to Secretary Tom Vilsack (132 KB PDF)

Comments to the Emerging Issues Task Force (EITF) regarding Issue No. 08-1, "Revenue Arrangements with Multiple Deliverables" (January 23, 2009)
Read the comments (65 KB PDF)

Comments, draft study entitled "Study on the relationship between the ABS International Regime and other international instruments which govern the use of genetic resources: the World Trade Organization (WTO), the World Intellectual Property Organization (WIPO), and the Union for the Protection of New Varieties of Plants (UPOV)" (January 22, 2008)
Read the comments (93.6 KB PDF)

FDA Draft Guidance for Industry on Process Validation: General Principles and Practices; Availability (January 21, 2009)
BIO comments to the FDA (103 KB PDF)

FDA Draft Guidance on Potency Tests for Cellular and Gene Therapy Products (January 6, 2009)
BIO comments to the FDA (106 KB PDF)

Comments on Licensure and Regulation of Pharmaceutical Detailers in the District of Columbia and the SafeRx Amendment Act of 2008 (December 22, 2008)
BIO comments to the District of Columbia Department of Health (782 KB PDF)

Comments on Competition Issues Involving Follow-on Biologic Drugs (December 22, 2008)
BIO comments to the FTC (1 MB PDF)

Ideas for Reform of the US Patent & Trademark Office: BIO Letter to President-Elect Obama (December 17, 2008)
Read the comments (178 KB PDF)

Letter to USDA Advisory Committee on Agricultural Biotechnology for 21st Century outlining BIO's views regarding USDA’s oversight of genetically engineered animals (December 17, 2008)
Letter to USDA Advisory Committee Executive Director Dr. Michael Schechtman (1 MB PDF)

Comments to Korea Food and Drug Administration (KFDA) regarding Labeling Standards for Genetically Modified Foods (December 15, 2008)
BIO letter to KFDA (2 MB PDF)

FDA Draft Guidance on End-of-Phase 2A (EOP2A) Meetings (November 25, 2008)
BIO comments to the FDA

Comments on USDA APHIS Proposed Rule Changes to 7 CFR Part 340 (November 24, 2008)
BIO letter to APHIS (3.5 MB PDF)

Frequently Asked Questions: Licensure and Regulation of Pharmaceutical Detailers document (November 20, 2008)
BIO comments on the District of Columbia’s draft SafeRx (2.63 MB PDF)

Comments on the draft guidance regarding the regulatory framework for Genetically Engineered Animals (November 18, 2008)
BIO comments to the FDA

Response to USDA's Animal and Plant Health Inspection Service (APHIS) request for information on Genetically Engineered Animals (November 18, 2008)
BIO's comments to the USDA

Testimony on Behalf of BIO to the House Energy and Commerce Subcommittee on Health (November 13, 2008)
Rachel King, CEO of GlycoMimetics, Inc., testified on behalf of BIO in the hearing entitled, "Treatments for an Ailing Economy: Protecting Health Care Coverage and Investing in Biomedical Research."
Read the testimony

International Conference on Harmonisation; Draft Guidance on E2F Development Safety Update Report (DSUR) (November 3, 2008)
BIO comments to the FDA

"Computerised Systems", Annex 11 to the EU’s GMP Guide (October 31, 2008)
BIO's comments to the EU’s Enterprise and Industry Directorate-General regarding proposed updates to Annex 11
Read the comments

BIO comments (Fed. Reg. 73:57047) regarding its Notice of Intent (NOI) to prepare an Environmental Impact Statement (EIS) for the Biomass Crop Assistance Program (BCAP) (October 31, 2008)
BIO Letter to Community Credit Corporation (128 KB PDF)

Section 102 Certification Requirements of the Consumer Product Safety Improvement Act of 2008 (October 29, 2008)
BIO comments to the Consumer Product Safety Commission

Letter to ANSI Supporting USDA’s Appeal on the Status of the Leonardo Academy (October 28, 2008)
BIO letter to ANSI (108 KB PDF)

BIO comments on the proposed rulemaking, SEC Release No. 34-58572, by the Securities and Exchange Commission (October 27, 2008)
Read the comments (106 KB PDF)

BIO comments relevant to the implementation of Sec. 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (October 27, 2008)
BIO comments to FDA (82 KB PDF)

Comments on Proposed Rule 603-052-1236: To Establish a System for Review of Federal Permit Applications For Growing Biopharmaceutical Crops In Oregon (October 24, 2008)
BIO letter to State Department of Agriculture in Oregon (61 KB PDF)

BIO Letter in Support of Increased Funding for NIH and PHSSEF (October 24, 2008)
BIO urges Congressional leaders to include increased funding for NIH and PHSSEF should they consider another economic stimulus package.
Read the comments (78 KB PDF)

Concerns over the implementation of the Renewable Fuels Standards lifecycle greenhouse gas emissions standards mandated by the Energy Independence and Security Act of 2007 (October 23, 2008)
BIO's comments to the EPA (237 KB PDF)

BIO comments on matters to be addressed by the Technical Expert Group on Concepts, Terms, Working Definitions and Sectoral Approaches ("Concepts TEG") under the Convention on Biological Diversity (CBD) (October 17, 2008)
Read the comments (534 KB PDF)

BIO comments on Fish and Wildlife Service Interagency Cooperation Under the Endangered Species Act (October 15, 2008)
BIO comments to Fish and Wildlife Service (78 KB PDF)

Comments of the Biotechnology Industry Organization (BIO) to the request of the 12th session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) (October 9, 2008)
Read the comments (139 KB PDF)

FDA Draft Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings (October 6, 2008)
Read the comments (117 KB PDF)

BIO Provides Response to FTC Questions on Follow-on Biologics (October 1, 2008)
BIO suggested to the FTC that patient safety and data exclusivity to preserve biomedical innovation should stand at the center of a regulatory approval pathway for follow-on biologics.
Read the comments (353 KB PDF)

Comments regarding the CMS Posting of Potential National Coverage Decision Topics (Potential NCD List)(September 26, 2008)
BIO comments to CMS (161 KB PDF)

Whether Form FDA 3674 should accompany all clinical submissions to an Investigational New Drug (IND) file (September 24, 2008)
BIO comments to OMB regarding certification to accompany drug, biological product, and device applications or submissions
Read the comments (139 KB PDF)

Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (September 23, 2008)
Comments on the Department of Defense’s proposed rule to implement Section 703 of the National Defense Authorization Act for Fiscal Year 2008.
Read the comments (155 KB PDF)

BIO applaudes the SEC’s recent rulemaking regarding investor protections against abusive "naked" short selling for all public companies. (September 22, 2008)
BIO urges the SEC to issue proposed rulemaking that would provide adequate disclosures of short positions to the SEC and to the public.
Read the comments (66 KB PDF)

BIO Letter in Support of Increased Funding for FDA and NIH in Continuing Resolution for FY2009 (September 17, 2008)
BIO letter to Senator Robert C. Byrd, Chairman of the Senate Committee on Appropriations
Read the letter (113 KB PDF)

Comments regarding Independence of and Commercial Support for Continuing Medical Education (CME) (September 12, 2008)
BIO comments to the Accreditation Council for Continuing Medical Education (460 KB PDF)

Expansion of the ClinicalTrials.gov Database (September 8, 2008)
BIO comments regarding implementation of Title VIII of the Food and Drug Administration Amendments Act of 2007
Read the comments (146 KB PDF)

Comments to the CY 2009 Outpatient Prospective Payment System (OPPS) Proposed Rule (September 2, 2008)
BIO comments to CMS (795 KB PDF)

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for Calendar Year 2009 (August 29, 2008)
BIO comments to CMS (337 KB PDF)

Requirements for Pregnancy and Lactation Labeling (August 27, 2008)
BIO comments to the FDA (145 KB PDF)

The World Medical Association reviews the Declaration on Helsinki (August 25, 2008)
BIO comments to WMA (251 KB PDF)

Supplemental Comments to EPA regarding the ANPR on Plant-Incorporated Protectants; Potential Revisions to Current Production Regulations (EPA-HQ-OPP-2006-1003) (August 6, 2008)
BIO and ASTA Letter to EPA (91 KB PDF)

BioPreferred Voluntary Labeling Program (August 1, 2008)
BIO comments to the U.S. Department of Agriculture (68 KB PDF)

Pilot Program to Evaluate Proposed Name Submissions (July 31, 2008)
BIO comments to the FDA (41 KB PDF)

Comments to the World Intellectual Property Organization on the draft Gap Analysis on the Protection of Traditional Knowledge (July 3, 2008)
Read the comments (153 KB PDF)

BIO Comments to the EPA on the Clean Air Act ("CAA") (June 23, 2008)
BIO comments regarding the Clean Air Act ("CAA") for a waiver of 50 percent of the Renewable Fuel Standard ("RFS") mandate for the production of ethanol from grain.
Read the comments (83 KB PDF)

BIO Comments on FDA’s Draft Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (June 19, 2008)
BIO comments to the FDA (142 KB PDF)

Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates (June 13, 2008)
BIO comments to CMS (169 KB PDF)

BIO letters in support of proposal to allow companies to accelerate the use of R&D and AMT tax credits (June 12, 2008)
BIO's Letters to House and Senate Leaders
Read BIO's letter (111 KB PDF)
Read BIO's letter to Senate (109 KB PDF)
Read BIO's letter to House (109 KB PDF)

Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets (June 6, 2008)
Read the comments (148 KB PDF)

Concept Paper on a Guideline on the Chemical and Pharmaceutical Quality Documentation Concerning Biological Investigational Products in Clinical Trials (May 30, 2008)
BIO comments to the EMEA (96 KB PDF)

Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments (May 19, 2008)
BIO comments to the FDA (80 KB PDF)

Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information (May 19, 2008)
BIO comments to the FDA (43 KB PDF)

Jim Greenwood testifies before the House Energy and Commerce Subcommittee on Health regarding the drug safety provisions of the discussion draft of the Food and Drug Administration Globalization Act. (May 1, 2008)
Read the testimony (100 KB PDF)

BIO Principles on Vaccine Financing Policy (April 30, 2008)
Read the comments (99 KB PDF)

Reprint Practices for the Distribution of Medical Journal Articles et al. on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (April 21, 2008)
BIO comments to the FDA (142 KB PDF)

BIO's Letter Supporting S.358, the Genetic Information Nondiscrimination Act (GINA) (April 15, 2008)
Letter to The Honorable Edward M. Kennedy (76 KB PDF)
Letter to The Honorable Olympia J. Snowe (76 KB PDF)

Letter Urging USDA to Issue Final Revisions to 7 CFR Part 340 by End of 2008 (April 15, 2008)
Letter to USDA Secretary Ed Shafer (140 KB PDF)

Steps Tricare Management Activity (TMA) has taken to implement a new rebate regime (April 10, 2008)
Comments on prescriptions filled through the Tricare Retail Pharmacy Network (171 KB PDF)

Ag Trade letter supporting Ellen Terpstra's nomination as Chief Ag negotiator (April 4, 2008)
Letter to Senate Finance Committee (86 KB PDF)

Medicare Program; Town Hall Meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) (April 3, 2008)
BIO comments to CMS April 30th public meeting of MedCAC
Read the comments (192 KB PDF)

Statement to the Coverage and Analysis Group of the Centers for Medicare & Medicaid Services (March 14, 2008)
BIO comments to CMS regarding adding compendia for the purposes of making medicare coverage determinations
Read the comments (110 KB PDF)

Proposed Revised Annex 2: Manufacture of Biological Medicinal Products for Human Use (March 14, 2008)
BIO comments to the EMEA (153 KB PDF)

Statement to the Advisory Panel on Ambulatory Payment Classification Groups (March 7, 2008)
BIO's testimony before the Advisory Panel on Ambulatory Payment Classifications regarding the policies the CMS has adopted and is considering adopting for drug and biological therapies.
Read the comments (216 KB)

BIO Comments to Brazilian Bill (February 28, 2008)
BIO submitted comments in response to the public consultation requested by the Office of the President, Subsector for Legal Affairs (Casa Civil da PresidÍncia da Rep˙blica, Subchefia para Assuntos JurÌdicos), regarding the draft bill of law covering the collection of biological material, access to genetic resources and their derivatives for scientific or technological research, remittance and transport of biological material, access to and protection of the associated traditional knowledge and rights of farmers and the sharing of benefits.
Read the comments (160 KB PDF)

Comments on the Identification of Countries involving the Special 301 Provisions (February 11, 2008)
BIO's letter to the Office of the U.S. Trade Representative (181 KB PDF)

Comments on the changes to the Hospital Outpatient Prospective Payment System (January 28, 2008)
BIO comments on the CMS final rule regarding revisions to the hospital outpatient prospective payment system and 2008 payment rates
Read the comments (214 KB PDF)

Comments on the Medicare Advantage-Prescription Drug (MA-PD), Cost-Based Plan, and Stand Alone Prescription Drug Plan (PDP) (January 30, 2008)
BIO comments on the Centers for Medicare & Medicaid Services ­ Draft 2009 Medicare Advantage
Read the comments (190 KB PDF)

Proposed changes to the 2010 Healthcare Common Procedure Coding System (HCPCS) (December 10, 2007)
BIO comments on proposed changes to the 2010 HCPCS Level II Modification Process
Read BIO comments (192 KB PDF)

Comments on the treatment of prescription drugs under the Medicaid Drug Rebate Program (December 21, 2007)
A letter from BIO to the Centers for Medicare and Medicaid Services' (CMS)
Read the comments (244 KB PDF)

Comments on the USP Draft Medicare Model Guidelines Version 4.0 (December 6, 2007)
BIO comments to the United States Pharmacopeia regarding the USP Draft Medicare Model Guidelines (190 KB PDF)

Comments on the importance of NIH funding in the FY2008 LHHSE Appropriations Bill (October 25, 2007)
A letter from BIO (and other biotech leaders) to House Leaders regarding NIH Funding for FY2008
Read the comments (72 KB PDF)

Comments to the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (“IGWG”) (October 3, 2007)
BIO comments regarding drawing up a global strategy and plan of action on public health innovation and intellectual property for developing countries.
Read the comments (312 KB PDF)

Comments regarding In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) (August 27, 2007)
BIO's letter to the FDA (153 KB PDF)

BIO's Statement on the Bayh-Dole Act (August 27, 2007)
BIO's statement before the House Science and Technology Subcomittee on Technology and Innovation (78 KB PDF)

Concerns with compliance information on China's WTO commitments (August 16, 2007)
Letter to the U.S. Council for International Business (288 KB PDF)

Coalition Supports Tax Legislation to Advance Renewable Energy (July 30, 2007)
A coalition of 18 renewable energy groups, including BIO, sent a letter to Senators asking them to support tax legislation that will transform the United States into a world leader in renewable and clean energy technologies.
Read the comments (71 KB PDF)
Read the press release

Comments Regarding Proposed Exemptions for Plant-Incorporated Protectants Derived from Plant Viral Coat Protein Genes (July 17, 2007)
Letter to Office of Pesticide Programs (EPA) (329 KB PDF)

Chemical, Biological, Radiological, and Nuclear Threats (July 13, 2007)
BIO comments on HHS' Public Health Emergency Medical Countermeasure Implementation Plan (174 KB PDF)

Comments Regarding Proposed Revisions to Regulation of Plant-Incorporated Protectants (July 13, 2007)
Letter to Office of Pesticide Programs (EPA) (1.16 MB PDF)

Use of Medication Guides to Distribute Drug Risk Information to Patients (July 11, 2007)
BIO comments to the FDA (33 KB PDF)

Agricultural Biotechnology in China (June 29, 2007)
ASTA and BIO Joint Letter to USDA FAS Administrator Michael Yost (998 KB PDF)

Patent Law Harmonization (June 22, 2007)
BIO Letter to the Patent and Trademark Office (525 KB PDF)

Food Plus Fuel, Not Food or Fuel
Myths and Facts: Food and Fuel

Erythropoiesis Stimulating Agents (ESAs) (June 13, 2007)
BIO comments regarding CMS' proposed restrictions for FDA approved uses and off-label uses.
Read the comments (201 KB PDF)

Inpatient Prospective Payment System (June 12, 2007)
BIO comments regarding CMS' proposed 2008 changes (232 KB PDF)