With global regulatory changes happening quickly and often, there is concern that sponsors need more robust systems to keep pace and have a global disclosure strategy in place.
CDRH announced its top 10 Regulatory Science Priorities for Fiscal Year 2016, and stated that these priorities are more than a mere philosophical statement of topics of interest; rather, these priorities are expected to influence CDRH intramural funding decisions.
Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.
French safety authority confirms what had been speculated--Phase I volunteers received the fifth of the highest dose escalation of the investigational drug at the same time, which goes against EMA recommendations.
FDA will provide expert scientific, clinical and statistical input to guide the further enhancement of CCDA to support FDA reviewers in rapidly detecting and investigating safety signals during new drug application (NDA) reviews and post-market pharmacovigilance activities.
The EU-AIMS Longitudinal European Autism Project (LEAP) is combining genetic testing, neuroimaging, cognitive testing and clinical assessments to identify biological risk markers associated with subtypes of autism.
Amgen, Celgene, Independence Blue Cross, Bank of America and many more collaborate to deliver immunotherapies more quickly to cancer patients through historic drug development alliance.
ECT is comprised of two primary services, Protocol+ for the registration of trials and Results Services for the publications of trial results.