Home » Conferences & Events » Health Care » Food and Drug Administration Review

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...

More Articles →

Letters, Testimony & Comments

PBRER: BIO Comments on Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
May 8 2013
BIO thanks the Food and Drug Administration for the opportunity to submit comments on the “Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format .”
eSource: BIO Comments on FDA Draft Guidance on Electronic Source Data in Clinical Investigations
March 26 2013
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
February 4 2013
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 pathway for biosimilar and interchangeable biological products.
BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements
March 29 2012
More Letters, Testimony & Comments →

Press Releases

2012 BIO International Convention to Highlight the FDA and Regulatory Environment
May 9 2012
Global event for biotechnology to be held June 18-21, 2012 in Boston.
Release of FDA Guidance for Biosimilars Pathway Marks Important Step Forward, Says BIO
February 9 2012
BIO President and CEO Jim Greenwood issued the following statement regarding the newly released U.S. Food and Drug Administration (FDA) guidance for the review and approval of biosimilars.
New Study Shows the Rate of Drug Approvals Lower than Previously Reported
February 14 2011
Biotechnology Industry Organization (BIO) Industry Analysis and  BioMedTracker (BMT) announced results of a study today that shows the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is  near one in 10.
BIO Celebrates Senate Passage of PDUFA Reauthorization Package
September 21 2007
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding Senate passage of the reauthorization of the Prescription Drug User Fee Act (PDUFA)
BIO Commends House for Approving PDUFA Reauthorization Package
September 19 2007
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement following passage by the House of Representatives of the reauthorization of the Prescription Drug User Fee Act (PDUFA) today.
More Press Releases →