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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

Cell and Gene Therapy: BIO Comments on Preclinical Assessment of Investigational Cellular and Gene Therapy Products
February 27 2013
Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format
February 19 2013
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
February 4 2013
Data Standards: BIO Comments on Development of Prioritized Therapeutic Data
January 22 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Development of Prioritized Therapeutic Data Standards (the Notice).”
IRB: BIO Comments on Draft Guidance for IRBs
January 22 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for IRBs, Clinical Investigators, and Sponsors."
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Press Releases

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.
BIO Testifies on Importance of Prompt Enactment of PDUFA V Recommendations
February 1 2012
In the testimony, Richard Pops, Alkermes plc Chairman and CEO,  stressed the need for a quick reauthorization of the Prescription Drug User Fee Act (PDUFA) and enactment of the enhancements recommended in the PDUFA V agreement. 
BIO Statement on “Food Labeling” Petition to FDA
October 4 2011
A coalition of anti-technology groups under the moniker “Just Label It” has reportedlysubmitted a petition to the U.S. Food and Drug Administration (FDA) calling for the mandatory labeling of foods that have been grown using agricultural biotechnology.
BIO Supports Timely Reauthorization of PDUFA to Promote the Development of Innovative Therapies and Speed New Medicines to Patients
September 1 2011
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on the Prescription Drug User Fee Act (PDUFA) V recommendations as published by the U.S. Food and Drug Administration (FDA).
Hill Leadership: Support Science-Based Assessments by FDA
August 3 2011
Animal Agriculture Coalition Members denounce political interference in FDA process.
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