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,...

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BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for IRBs, Clinical Investigators, and Sponsors."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).”
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.
July 29 2013
BIO released a statement in support of the FDA Safety Over Sequestration Act (H.R. 2725), which would exempt user fees, including those paid by BIO member companies, from the operation of sequestration.
February 9 2012
BIO President and CEO Jim Greenwood issued the following statement regarding the newly released U.S. Food and Drug Administration (FDA) guidance for the review and approval of biosimilars.
February 1 2012
In the testimony, Richard Pops, Alkermes plc Chairman and CEO,  stressed the need for a quick reauthorization of the Prescription Drug User Fee Act (PDUFA) and enactment of the enhancements recommended in the PDUFA V agreement.