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Andrew Emmett on PDUFA and the 2012 BIO International Convention

Andrew Emmett, Managing Director, Science & Regulatory Affairs, speaks about the important regulatory issues facing the industry, specifically PDUFA reauthorization, the FDA and regulation. Also, hear his programming highlights from the Achieving Regulatory Approval and Compliance Track at the upcoming 2012 BIO International Convention.

FY2011 Innovative Treatment Approvals

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

PDUFA V Recommendations Promote Development of Innovative Therapies

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.

Countdown to Partnering - John Carroll, Editor of Fierce Biotech

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

The Reimbursement Landscape for Novel Diagnostics: Current Limitations.

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.

Healing, Fueling, Feeding: How Biotechnology Is Enriching Your Life.

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.

Health Reform Debate Heats Up and Slows Down

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

Guide to Biotechnology 2008

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.

2007-2008 BIO Milestones

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.

Facilitating Research and Discovery

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.

What You Do Could Change the World. What BIO Does Helps Change Your World.

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

Everywhere You Look Biotechnology Touches Your Life

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?

Letters, Testimony & Comments

SMU: BIO Comments on Creating an Alternative Approval Pathway for Certain Drugs to Address Unmet Medical Need
March 1 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
PDUFA V: BIO Comments on FDA's NME Review Program Assessment
August 5 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
BIO's Letter of Support for Passage of H.R. 5651, Food and Drug Administration Reform Act of 2012
May 30 2012
Dear Speaker Boehner and Minority Leader Pelosi: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express...
BIO's Suppport for the Reauthorization of the Prescription Drug User Fee Act (PDUFA V)
May 10 2012
    Dear Chairman Upton and Ranking Member Waxman: On behalf of the Biotechnology Industry Organization (BIO), I am...
BIO Endorsement Letter for the Senate Health, Education, Labor and Pensions Committee Markup of the Food and Drug Administration Safety and Innovation Act (FDASIA)
May 2 2012
      On behalf of the Biotechnology Industry Organization (BIO), I am writing to express support for the Food...
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Press Releases

PDUFA V Sets New Course for Regulatory Science – Joint BIO/PhRMA Statement
October 1 2012
Washington, D.C. (October 1, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) President and...
BIO Commends Senate for Approval of User Fee Package
June 27 2012
FDASIA headed to President for signature into law Washington, D.C. (June 26, 2012) –Biotechnology Industry...
BIO Hails House Passage of Reconciled User Fee Package
June 21 2012
  Washington, D.C. (June 21, 2012) –Biotechnology Industry Organization (BIO) President and CEO Jim...
BIO Lauds Senate Passage of User Fee Package
May 24 2012
Washington, D.C. (May 24, 2012) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood...
2012 BIO International Convention to Highlight the FDA and Regulatory Environment
May 9 2012
WASHINGTON, DC – (May 9, 2012) – The U.S. regulatory environment strongly impacts innovation and the...
More Press Releases →