Food and Drug Administration

The 14th Annual BIO CEO & Investor Conference was held on February 13-14 in New York City at the Waldorf=Astoria

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.

While the U.S. leads in the area of biotechnology, there is no guarantee this competitive edge will continue.

Regulatory review processes are not keeping up with rapidly advancing science and are making the environment for developing new treatments and preventions for deadly and debilitating diseases more difficult.

Society has tapped just a small fraction of the many potential uses and benefits of biotechnology.

You might have heard that the Prince of Wales, just days after hosting the Royal Wedding, paid us a visit here in Washington.  Prince Charles, a long-time organic food advocate and self-described environmentalist, was here to speak at a Washington Post symposium on the Future of Food.

Multiple sclerosis (MS) is a complex disease involving immune-system attacks on the central nervous system. Research into MS involves questions that dovetail many fields of science, including immunology, neuroscience, psychology and more.

A new report analyzing FDA-approved monoclonal antibodies (mAbs) produced by a select group of leading biotechnology companies shows that clinical development times – specifically the duration of Phase II and Phase III trials – are lengthening, while FDA review times have remained constant.

Current rules resulting from a 2003 Office of Hearings and Appeals decision have inhibited and interfered with the growth and survival of small private biotechnology companies and the development of promising technologies and products

President’s call for more funding comes as Congress focuses on reducing budget deficits.

In this presentation, BIO urges the Food and Drug Administration to prioritize patient safety and incentives for innovation at a public hearing on biosimilars.

Biotech research holds a great deal of promise for future innovation in the treatment of previously untreatable diseases. But how long does it take for a biotech therapy to come to market?

Letters, Testimony & Comments

February 4 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to provide comments on the proposal to create an alternative approval pathway for certain drugs intended to address unmet medical need, also referred to as a Special Medical Use (SMU) designation.
January 22 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for IRBs, Clinical Investigators, and Sponsors."
January 22 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Development of Prioritized Therapeutic Data Standards (the Notice).”

Press Releases

February 24 2016
“BIO extends our congratulations to Dr. Califf on his confirmation as Commissioner of the FDA, a job that carries tremendous responsibility in protecting public health and advancing biotechnology innovation. 
January 7 2015
Biosimilars raise novel and complex questions of science and law that require updated legal and regulatory frameworks
August 6 2014
Survey responses will help inform Prescription Drug User Fee Act VI negotiations
January 30 2014
Patients Should Be Informed if Doctor's Prescription Changed
November 18 2013
BIO commends the Senate for approving H.R. 3204, the Drug Quality and Security Act.