PDUFA

Andrew Emmett on PDUFA and the 2012 BIO International Convention April 12, 2012 Andrew Emmett, Managing Director, Science & Regulatory Affairs, speaks about the important...	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,...	Countdown to Partnering - John Carroll, Editor of Fierce Biotech April 7, 2011 John Carroll, editor of Fierce Biotech, shares what he won't miss at the 2011 BIO...

Letters, Testimony & Comments

Benefit-Risk: BIO Comments on FDA's Prescription Drug User Fee Act V Benefit-Risk Plan

May 7 2013

BIO thanks the Food and Drug Administration for the opportunity to submit comments on the FDA Draft Plan on “Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making.”

SMU: BIO Comments on Creating an Alternative Approval Pathway for Certain Drugs to Address Unmet Medical Need

March 1 2013

PDUFA V: BIO Comments on FDA's NME Review Program Assessment

August 6 2012

BIO's Letter of Support for Passage of H.R. 5651, Food and Drug Administration Reform Act of 2012

May 30 2012

BIO's Suppport for the Reauthorization of the Prescription Drug User Fee Act (PDUFA V)

May 10 2012

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Press Releases

PDUFA V Sets New Course for Regulatory Science – Joint BIO/PhRMA Statement

October 1 2012

Pharmaceutical Research and Manufacturers of America PhRMA President and CEO John J. Castellani and BIO President and CEO Jim Greenwood released the following joint statement on the implementation of the Prescription Drug User Fee Act (PDUFA V).

BIO Commends Senate for Approval of User Fee Package

June 27 2012

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on passage of S. 3187, the Food and Drug Administration Safety and Innovation Act (FDASIA), by the U.S. Senate.

BIO Hails House Passage of Reconciled User Fee Package

June 21 2012

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on unanimous passage of S. 3187, the Food and Drug Administration Safety and Innovation Act (FDASIA), by the U.S. House of Representatives.

BIO Lauds Senate Passage of User Fee Package

May 24 2012

BIO commends the bipartisan Senate approval of FDASIA, which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA).

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.

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