PDUFA

April 11, 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...

Letters, Testimony & Comments

July 14 2015
On behalf of the Biotechnology Industry Organization (BIO), thank you for the opportunity to provide our comments on the success of the PDUFA program and recommendations to enhance the program through the user fee reauthorization process.
June 8 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the revised draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products.”
July 27 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA, the Agency) for the opportunity to submit comments on the Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs.
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 12 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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.” BIO commends FDA on the release of this Draft Guidance and shares the Agency’s commitment to ensure that safe and effective medicines are available for children.

Press Releases

August 6 2014
Survey responses will help inform Prescription Drug User Fee Act VI negotiations
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).