On October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures ...

More than half of transplant recipients in a large analysis developed chronic graft-versus-host disease, and 15% died from causes other than cancer relapse. Those numbers capture the uneasy truth of ...

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 ...

Last week, FDA issued the final version of its 2023 revised draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers,” which ...

The Journal of Clinical Investigation (JCI or J Clin Invest) is a leading biomedical journal, with a 2008 impact factor of 16.559. The journal makes its research articles -- including access to ...

Qure stock plunged 45% after FDA rejected AMT-130 approval pathway, requiring new randomized trial for Huntington's disease gene therapy program.

Unfortunately, this book can't be printed from the OpenBook. If you need to print pages from this book, we recommend downloading it as a PDF. Visit NAP.edu/10766 to get more information about this ...

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 ...

To include children in a clinical trial, the ethical requirements under 21 CFR 50, subpart D, the Additional Safeguards for Children in Clinical Investigations, must be considered. Clinical ...

Biomedical and Clinical Sciences encompass a broad inter‐disciplinary field that bridges fundamental biological research with direct patient care. This area integrates molecular biology, genomics, ...

In the past few decades, tremendous evidence has emerged to drive the evolution of radiology from a qualitative discipline to a quantitative modern science. In particular, dynamic contrast-enhanced ...