FDA Releases MyStudies App for Patient Informed Consent

FDA Releases MyStudies App for Patient Informed Consent

The FDA released the app FDA MyStudies, which can be found in app stores as COVID MyStudies, for patients to provide informed consent for traditional clinical trials, real-world trials, observational studies, and registries. The app is free, as...
FDA Releases Guidance on Formal Meetings Amid COVID-19 Crisis

FDA Releases Guidance on Formal Meetings Amid COVID-19 Crisis

The FDA announced on Wednesday (5/27) new guidances via a Q&A format for how COVID-19 is impacting formal meetings, effective immediately. The guidance outlines that all meetings with the FDA will be held remotely, either through teleconference or video...
EMA Strengthens ENCePP Madate Due to COVID-19

EMA Strengthens ENCePP Madate Due to COVID-19

The European Medical Association (EMA) has strengthened the mandate for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).  Currently, the mandate works to strengthen how the risks and benefits of medicinal products...
Remote Devices: A New Age of Patient Centricity

Remote Devices: A New Age of Patient Centricity

A new age of patient centricity has dawned, and the need for remote patient engagement has become more crucial than ever. From being able to remotely visit COVID-19 patients, to continuously tracking patients participating in clinical trials, remote technology helps...
Moderna Notes Early Signs of Success in COVID-19 Vaccine

Moderna Notes Early Signs of Success in COVID-19 Vaccine

Today (5/18) Moderna announced that its clinical trial in the United States has started to see protective antibodies in data from 8 healthy individuals, chosen at random from a 45-person study. The study, which began in March, and found that the...