PDUFA

April 12, 2012

Andrew Emmett, Managing Director, Science & Regulatory Affairs, speaks about the important...

November 3, 2011

BIO President and CEO Jim Greenwood congratulated the FDA and biopharmaceutical sponsors for...

November 3, 2011

Underlying the PDUFA V recommendations are the principles that a science-based, transparent,...

April 7, 2011

 John Carroll, editor of Fierce Biotech, shares what he won't miss at the 2011 BIO...

February 24 2014
The Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) are pleased to submit these comments in response to the Food and Drug Administration’s (FDA’s) Draft Prescription Drug User Fee Act V (PDUFA V) Information Technology Plan (IT Plan).
September 13 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.” BIO commends FDA on the release of this Draft Guidance and shares the Agency’s commitment to ensure that safe and effective medicines are available for children.
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.”
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).
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.
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.
May 24 2012
BIO commends the bipartisan Senate approval of FDASIA, which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA).  
May 9 2012
Global event for biotechnology to be held June 18-21, 2012 in Boston.