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FDA Review

Capital Conundrum
August 2, 2011

The biotech industry has shrunk dramatically in recent years based primarily on the continued...

Applying A Holistic Approach to Solve a Complex Disease
May 13, 2011

Multiple sclerosis (MS) is a complex disease involving immune-system attacks on the central...

New Report Shows Monoclonal Antibody Development Times Are Lengthening
May 4, 2011

A new report analyzing FDA-approved monoclonal antibodies (mAbs) produced by a select group of...

The Cost of Losing Innovation
April 11, 2011

Current rules resulting from a 2003 Office of Hearings and Appeals decision have inhibited and...

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Letters, Testimony & Comments

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...
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...
BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements
March 29 2012
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name...
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...
BIO Statement to the Presidential Commission for the Study of Bioethical Issues: Principles Regarding Ethical Performance of International Clinical Trials
November 16 2011
Given by Russell M. Medford, MD, PhD President and CEO, Salutria Pharmaceuticals, LLC BIO Board Standing Committee on Bioethics Co-...
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Press Releases

2012 BIO International Convention to Highlight the FDA and Regulatory Environment
May 9 2012
WASHINGTON, DC – (May 9, 2012) – The U.S. regulatory environment strongly impacts innovation and the...
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...
New Study Shows the Rate of Drug Approvals Lower than Previously Reported
February 14 2011
WASHINGTON, D.C. (Monday, February 14, 2011) - Biotechnology Industry Organization (BIO) Industry Analysis and ...
BIO Celebrates Senate Passage of PDUFA Reauthorization Package
September 21 2007
WASHINGTON, D.C. (September 21, 2007) -- Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood...
BIO Commends House for Approving PDUFA Reauthorization Package
September 19 2007
WASHINGTON, D.C. (September 19, 2007) -- Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood...
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