Home » Areas of Work » Public Policy » Regulatory Affairs

Regulatory Affairs

Andrew Emmett on PDUFA and the 2012 BIO International Convention
April 12, 2012

Andrew Emmett, Managing Director, Science & Regulatory Affairs, speaks about the important...

Panelists Go Inside the FDA at the BIO CEO & Investor Conference
February 22, 2012

The 14th Annual BIO CEO & Investor Conference was held on February 13-14 in New York City...

Successful State Initiatives That Encourage Bioscience Industry Growth
February 9, 2012

State governments in 2011 continued to see regional economic growth in the life sciences...

Podcast: BIO Media Briefing Highlights 2012 Policy Priorities
January 25, 2012

BIO President & CEO Jim Greenwood and Tom Watkins, President & CEO of Human Genome...

More Articles →

Letters, Testimony & Comments

Biosimilars: BIO Comments on FDA's Biosimilars User Fee Cover Sheet
May 14 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
Risk Evaluation: BIO Comments on ICH's Proposed Guideline on E2C(R2) Periodic Benefit-Risk Evaluation Report
May 11 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
Letter to the Texas Health and Human Services Commission Regarding Proposed Specialty Pharmacy Rule
March 1 2012
February 22, 2012 Texas Health and Human Services Commission Attn: Stacey Johnston Policy Analyst Medicaid/Children’s Health...
Biologics: BIO Comments on EMA 'Concept Paper on the Revision of the Guideline on Similar Biological medicinal Product"
February 29 2012
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments...
Good Guidance Practices: FDA Report on Good Guidance Practices: Improving Efficiency and Transparency
February 29 2012
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to comment on...
More Letters, Testimony & Comments →

Press Releases

Release of FDA Guidance for Biosimilars Pathway Marks Important Step Forward, Says BIO
February 9 2012
Patient Safety Must Remain Top Priority Washington, D.C. (February 9, 2012) — Biotechnology Industry...
BIO Comments on New Initiatives to Grow Nation’s Bioeconomy
September 16 2011
Washington, D.C. (September 16, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim...
Synthetic Biology’s Potential for Commercial Innovation Should Be Supported, BIO Argues
September 1 2011
WASHINGTON, D.C.(Sept. 1, 2011) – Research and development in synthetic biology is an evolution of...
BIO Unveils Strategic Initiative to Speed Scientific Breakthroughs, Develop Cures and Grow the Bio-Economy
June 29 2011
WASHINGTON, D.C. (Wednesday, June 29, 2011) - The Biotechnology Industry Organization (BIO) released today a summary...
Illinois Governor Pat Quinn Selected as BIO Governor of the Year
June 9 2011
WASHINGTON, D.C. (Thursday, June 09, 2011) - The Biotechnology Industry Organization (BIO) announced today its...
More Press Releases →