Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward
In March of 2019 the FDA released this statement regarding the value of Expanded Access Programs and the FDA’s encouragement of Sponsors to consider providing them as options for Patient Populations.
A few interesting statements worth highlighting in the statement:
“Since 2010, drug sponsors and manufacturers have given the opportunity of such access to more than 13,000 patients. The FDA applauds those companies.”
“We want to reassure sponsors that providing a drug under EA very rarely impacts development timelines.”
“An FDA analysis of more than 10,000 EA applications from 2005 to 2014 shows that the incidence of a clinical hold due to an adverse event on an EA IND was 0.2 percent compared to 7.9 percent for clinical holds for all commercial investigational drug development programs.”
“It’s very rare that EA impacts a clinical development program in a negative way. In addition, while perhaps not commonplace, EA may add to the evidence for approval.”
For specific examples of how EA programs have helped clinical approvals, provided by the FDA please read the entire statement by following the link below.
About TrialSat and Our Involvement in Expanded Access Programs
TrialStat has been providing Data Management software for Clinical Trials since 2003 having delivered over 500 trials on a global basis. In the last five years we have embarked on what we feel is a Paradigm Shift in Data Management Technology by adapting our eClinical Suite, contracts and billing models to support all phases of clinical development including pre clinical toxicology studies, Phase 1, 2, 3 and Post Marketing, as well as Diagnostics, and Expanded Access Programs.