A quick and timely passage of PDUFA V will further empower FDA to promote the development of innovative medicines
BIO President and CEO Jim Greenwood congratulated the U.S. Food and Drug Administration (FDA) and biopharmaceutical sponsors for making 35 novel new treatments available to patients in FY11, including breakthrough therapies for lupus, hepatitis C, rare diseases, and devastating cancers. These advancements in patient care represent the leading edge of the next generation of biotechnology innovations.
BIO looks forward to working with FDA to build upon these accomplishments by further strengthening FDA’s review processes, promoting regulatory flexibility under FDA’s expedited approval pathways, and enhancing predictability and consistency in the regulatory environment. In addition, a quick and timely passage of PDUFA V will further empower FDA to promote the development of innovative medicines and ensure that patients have timely access to safe and effective therapies.
The full FDA report is available online.