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Food and Drug Administration

Developing Policies that Foster Innovation
March 28, 2012

Acorda Therapeutics' Ron Cohen presented testimony on the importance of federal policies...

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...

FY2011 Innovative Treatment Approvals
November 3, 2011

BIO President and CEO Jim Greenwood congratulated the FDA and biopharmaceutical sponsors for...

PDUFA V Recommendations Promote Development of Innovative Therapies
November 3, 2011

Underlying the PDUFA V recommendations are the principles that a science-based, transparent,...

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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...
FDA Public Meeting: Approval Pathway for Biosimilar and Interchangeable Biological Products
May 11 2012
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval...
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...
Drug Safety: BIO Comments on FDA's Communication to the Public
May 8 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
Drug Safety: BIO Comments on FDA's Draft Guidance on Classifying Significant Postmarket Drug Safety Issues
May 8 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
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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 Testifies on Importance of Prompt Enactment of PDUFA V Recommendations
February 1 2012
Washington, D.C. (February 1, 2012) – Richard Pops, Chairman and CEO of Alkermes plc, testified today on behalf...
BIO Statement on “Food Labeling” Petition to FDA
October 4 2011
Washington, D.C. (October 4, 2011) – A coalition of anti-technology groups under the moniker “Just Label...
BIO Supports Timely Reauthorization of PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
September 1 2011
Washington, D.C. (September 1, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim...
Hill Leadership: Support Science-Based Assessments by FDA
August 3 2011
Washington, D.C. (August 3, 2011) – In a letter to Congressional Leadership, the Biotechnology Industry...
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