Food and Drug Administration

March 28, 2012

Acorda Therapeutics' Ron Cohen presented testimony on the importance of federal policies...

February 22, 2012

The 14th Annual BIO CEO & Investor Conference was held on February 13-14 in New York City...

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,...

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BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for IRBs, Clinical Investigators, and Sponsors."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.