Close

BIO Commends House for Approving PDUFA Reauthorization Package

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement following passage by the House of Representatives of the reauthorization of the Prescription Drug User Fee Act (PDUFA) today.

Testimony before the House Committee on Energy and Commerce, Health Subcommittee

The PDUFA program has been widely credited as an innovative program that has strengthened the Food and Drug Administration’s (FDA’s) capacity to evaluate the safety and effectiveness of new drugs and biologics, thereby expediting the availability of needed new therapies for patients.

Statement by BIO at FDA Public Meeting

The Biotechnology Industry Organization (BIO) welcomes this opportunity to comment on the success of the Prescription Drug User Fee Act (PDUFA) and the proposed enhancements for PDUFA IV.

Recommended Improvements to Prescription Drug User Fee Program Will Improve Drug Safety

The recommended improvements to the Prescription Drug User Fee Act (PDUFA) announced today by the Food and Drug Administration (FDA) will allow continued enhancement of FDA’s post-market safety capacity and help ensure careful, timely and transparent review of new drugs and biologics, said the Biotechnology Industry Organization (BIO).

Statement by BIO at FDA Public Meeting

Summary of PDUFA Changes

Letter Expressing Appreciation for the Creation of the Independent Consultants Program.

Docket No. 03D-0112

Reauthorization of the Prescription Drug User Fee Act

Docket No. 2004N-0267, Federal Register: July 20, 2004 (Volume 69, Page 43351)

BIO's final comments on FDA Draft Guidances on Risk Management

Development and Use of Risk Minimization Action Plans.

BIO's final comments on FDA Draft Guidances on Risk Management

Premarketing Risk Assessment.