FDA Still Most Predictable Part of Drug Development, Despite Bumps, Woodcock Says
This article was originally published in Pharmaceutical Approvals Monthly
Janet Woodcock may take a lot of criticism over problems with FDA’s drug application review and approval process, but she maintains sponsor success at gaining agency approval is better than any other portion of the development process.
You may also be interested in...
In a report both boastful and defensive in tone, the agency explains why some disease areas are rife with targeted therapies while others have few or none.
Strategic plan says CDER will streamline its processes and may find activities that could be “cut altogether.”
Members will enter data into secure database, allowing trade groups to gauge trends and problems with the PDUFA V application review program – and giving industry a stronger negotiating position for the next user fee round.