PDUFA

BIO President and CEO Jim Greenwood congratulated the FDA and biopharmaceutical sponsors for making 35 novel new treatments available to patients in FY11.

Underlying the PDUFA V recommendations are the principles that a science-based, transparent, and well-managed review process that appropriately balances benefits and risks can enhance public trust and increase patient access to new medicines.

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

Personalized medicine has the potential to revolutionize patient care. The fundamental goal in advancing our healthcare system through personalized medicine is to deliver the right treatment to the right patient at the right time.

Biotechnology is all around us and is already a big part of our lives, providing breakthrough products and technologies to combat disease, reduce our environmental footprint, feed the hungry, and make useful products.

The health reform debate is heating up and, in at least one respect, slowing down a bit.

We have used the biological processes of microorganisms for 6,000 years to make useful food products, such as bread and cheese, and to preserve dairy products.

Today, the biotechnology industry is enjoying more success and influence than ever before. Our industry’s innovations continue to improve the lives of people worldwide, and the advancement of these innovations is supported by the work of BIO.

Gov. Deval Patrick (Mass.) and Former Gov. Jeb Bush (Fla.) chatted about everything from the high cost of prescription drugs and health care to biofuels.

There are many reasons why more biotech companies belong to BIO than to any other organization. Read on and you’ll see why.

Has a member of your family been vaccinated against hepatitis B? Do you know someone who has diabetes? Has anyone in your family had heart disease?

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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.”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.