Close

BIO Hails House Passage of Reconciled User Fee Package

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.

BIO's Letter of Support for Passage of H.R. 5651, Food and Drug Administration Reform Act of 2012

...

BIO Lauds Senate Passage of User Fee Package

BIO commends the bipartisan Senate approval of FDASIA, which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA).  

BIO's Suppport for the Reauthorization of the Prescription Drug User Fee Act (PDUFA V)

...

2012 BIO International Convention to Highlight the FDA and Regulatory Environment

Global event for biotechnology to be held June 18-21, 2012 in Boston.

BIO Endorsement Letter for the Senate Health, Education, Labor and Pensions Committee Markup of the Food and Drug Administration Safety and Innovation Act (FDASIA)

...

BIO's Testimony to the April 18, 2012 House Committee on Energy and Commerce, Subcommittee on Health Hearing on "FDA User Fees 2012: How Innovation Helps Patients and Jobs"

...

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.

BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA

Sara Radcliffe, Executive Vice President of Health at the Biotechnology Industry Organization (BIO), testified today on biosimilar user fees (BsUFA) and the Prescription Drug User Fee Act (PDUFA) before the Senate Health, Education, Labor and Pensions Committee.

BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements

...