Tufts CSDD eBooks
Tufts CSDD's eBook, the newest addition to our publication catalog, is a comprehensive compendium of Tufts CSDD research findings on FDA approval trends. Offered in long-form digital format for mobile or desktop consumption, this Tufts CSDD eBook provides timely and highly relevant e-reference materials to inform the research-based pharma and biotech industry, as well as other stakeholders involved in new medicines development.
FDA Trends: Path to Approval, Second Edition
Edited by: Dr. Christopher-Paul Milne, Director of Research and Research Associate Professor
Tufts Center for the Study of Drug Development
The FDA Trends: Path to Approval eBook is a comprehensive compilation of recent Tufts CSDD presentations and publications, government data, and expert perspectives related to FDA approval trends. Offered in long-form digital format for mobile or desktop consumption, the eBook covers a broad range of topics, including FDA expedited review programs, the global marketplace, benefit/risk, regulatory science, and differential impact of FDA workload on therapeutic areas.
Second Edition - march 2018
The latest version of the eBook contains 30 pages of new material divided into two chapters – 2014/2015 and 2016/2017 Updates. The new chapters highlight many of the trends examined in earlier chapters revealing their trajectories as we move into the latter twenty-teens: the cost of drug development rising to over $2.5 billion; the dominance of oncology among FDA approvals and biotechnology in terms of pipeline growth. Updates also present a number of metrics analyses of therapeutic areas with ongoing significance – diabetes and cardiovascular disease – as well as those of emerging importance – immune-oncology and regenerative medicine. In addition, the Center’s new emphasis on operational studies is featured with graphics on industry studies of protocol amendments, ADE reporting, and utilization of real world evidence (RWE). Finally, issues that will likely be the focus of public debate and possible regulatory actions in 2018 are discussed.
What reviewers are saying:
"An excellent reference for medical and regulatory affairs teams.
"Offers valuable insights into regulatory processes and trends."
"Great overview of pertinent topics."