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Letters, Testimony & Comments

BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter
March 1, 2013
  BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter, submitted Friday, March 1.  BIO considers it especially important to focus attention on policies that impact access to...
SMU: BIO Comments on Creating an Alternative Approval Pathway for Certain Drugs to Address Unmet Medical Need
March 1, 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit written comments on the proposal to create an alternative approval pathway for certain drugs intended to address...
Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products
February 27, 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Guidance for Industry: Preclinical Assessment of...
BIO Comments on Colombia Biologics and Biosimilars Regulations
February 22, 2013
BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of biological origin. Many elements of the third draft appear to have addressed BIO’s previous comments with...
Medicaid, Children’s Health Insurance Programs, and Exchanges
February 21, 2013
Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 Re: CMS–2334–P; Medicaid,...
BIO Testimony Regarding Florida Renewable Fuel Standard Act
February 19, 2013
  Testimony of the Biotechnology Industry Organization (BIO) Hearing of the House Energy & Utilities Subcommittee February 19, 2013 Regarding Florida House Bill 4001: “AN ACT RELATING TO THE FLORIDA RENEWABLE FUEL...
Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format
February 19, 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance for Industry on Providing Submissions in Electronic Format...
2013 Special 301 Submission: BIO Provides Input on Biotech IP Challenges Around the Globe
February 8, 2013
Biotechnology companies provide unique benefits to the United States and the world. In the health care sector alone, the industry has developed and commercialized more than 300 biotechnology drugs and diagnostics and there are over 400 products in...
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
February 4, 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments on the proposal to create an alternative approval pathway for certain drugs intended to address unmet...
Monsanto v. Bowman: BIO submits Supreme Court Amicus Brief
February 4, 2013
BIO Comments on INPI Guidelines for Examination of Patent Applications
February 1, 2013
BIO commends the INPI for their efforts to devise guidelines for examining biotechnology related inventions. Given the technological advances and the innovation that spurs it are the primary drivers of economic growth in the modern era, it is...
BIO Comments on ANVISA Public Consultation N°66/2012
February 1, 2013
BIO respectfully submits both questions and comments for the National Health Surveillance Agency’s (ANVISA) consideration on the proposed rules.  BIO appreciates ANVISA’s desire to clarify their role in the review of patent...
Letter Supporting Florida House Bill 365; Pertaining to requirements for pharmacist to dispense substitute biological product
February 1, 2013
Representative Matt Hudson Florida House of Representatives 402 South Monroe Street Tallahassee, FL 32399 Dear Representative Hudson: The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology trade association...
CED: BIO's Comments in response to the Centers for Medicare and Medicaid Services’ (CMS) Draft Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development in the context of coverage decision
January 28, 2013
Dear Dr. Jacques:            The Biotechnology Industry Organization (BIO) is pleased to submit the following response to the Centers for Medicare and Medicaid Services’ (CMS) Draft...
BIO Principles on Patient Safety in the Substitution of Biologic Products
January 24, 2013
Biologics are complex medicines manufactured from living organisms. Unlike traditional “small molecule” drugs, biologics are not chemically synthesized but rather are manufactured from living cells by programming a particular cell line...
Statement in Support Of North Dakota S.B. 2190
January 24, 2013
The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology trade association. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations...
Statement in Opposition to North Dakota S. 2066
January 24, 2013
The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology trade association. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations...
IRB: BIO Comments on Draft Guidance for IRBs
January 22, 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities...
Data Standards: BIO Comments on Development of Prioritized Therapeutic Data
January 22, 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Development of Prioritized Therapeutic Data Standards (the Notice).”  BIO...
BIO Comments on India Guidelines for Examining Biotechnology Applications
January 18, 2013
Given the importance of protections for basic biotechnology inventions to the survival of the biotechnology sector in India, BIO has reviewed the Guidelines and is pleased to provide suggestions for possible improvement within the framework of the...