SMU: BIO Comments on Creating an Alternative Approval Pathway for Certain Drugs to Address Unmet Medical Need

Mar 1 2013


Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products

Feb 27 2013


BIO Comments on Colombia Biologics and Biosimilars Regulations

Feb 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 respect to clarity of structure and definitions of terms, as well as expectations for data requirements.   

Medicaid, Children’s Health Insurance Programs, and Exchanges

Feb 21 2013
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) proposed rule on the Medicaid, Children’s Health Insurance Programs (CHIP) and Exchanges Eligibility and Essential Health Benefits (EHB) provisions of the Patient Protection and Affordable Care Act (PPACA).

BIO Testimony Regarding Florida Renewable Fuel Standard Act

Feb 19 2013
Testimony of the Biotechnology Industry Organization (BIO) regarding Florida House Bill 4001: "An Act Relating to the Florida Renewable Fuel Standard Act; Repealing the Florida Renewable Fuel Standard Act".

Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format

Feb 18 2013


2013 Special 301 Submission: BIO Provides Input on Biotech IP Challenges Around the Globe

Feb 7 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 the pipeline.

SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need

Feb 3 2013
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 medical need, also referred to as a Special Medical Use (SMU) designation.

BIO Comments on INPI Guidelines for Examination of Biotechnology Patent Applications in Brazil

Feb 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 critical that patent laws and practices properly motivate and reward innovation.

BIO Comments on Brazil's ANVISA Public Consultation N°66/2012

Feb 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 applications for pharmaceutical products and processes.