WASHINGTON – Conducting clinical investigations of mitochondrial replacement techniques (MRT) in humans is ethically permissible as long as significant conditions and principles are met, says a new ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...

The FDA has finalized guidance on using electronic health record (EHR) data in clinical trials. With a nationwide push toward incorporating real-world evidence in decision making, the FDA has ...

The central objective of this series of five courses, listed below, is to increase the trainees’ skills in scientific grant writing and grantsmanship, and to facilitate discussion and honing of their ...

The International Medical Device Regulators Forum (IMDRF) recently released three final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices, replacing ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Seven Penn faculty members from the Perelman School of Medicine and the Children’s Hospital of Philadelphia have been elected to the American Society for Clinical Investigation. The American Society ...

CHICAGO – The principal lab for a nationwide coronavirus testing company under investigation by several states is now the focus of a federal agency probing allegations of misconduct at the site. The ...