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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

BIO Statement for the Presidential Commission for the Presidential Commission for the Study of Bioethical Issues on 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-...
Testimony before House Energy and Commerce Subcommittee on Health
July 7 2011
Paul Hastings, testifying on behalf of BIO, discussed the importance of biotechnology in providing cures to diseases, and creating high-...
BIO Submits Comments to FDA on "Biologics Price Competition and Innovation Act of 2009 (BPCIA)
June 9 2011
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
FDA's Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets
April 18 2011
Re: Docket No. FDA-2011-D-0057: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic...
BIO Comments on FDA Transparency Initiative: Improving Transparency to Regulated Industry
March 8 2011
Re: Docket No. FDA-2009-N-0247-0260: FDA Transparency Initiative: Improving Transparency to Regulated Industry Dear Sir/Madam: 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...
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...
Recommended Improvements to Prescription Drug User Fee Program Will Improve Drug Safety
January 11 2007
WASHINGTON, D.C. (January 11, 2007) -- The recommended improvements to the Prescription Drug User Fee Act (PDUFA)...
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