Tuesday, December 22, 2015
The FDA has issued final guidance outlining updated blood donor deferral recommendations to help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products. [Read More]
The Pulse on Study Conduct by Elizabeth Weeks-Rowe
To provide an informed consent process that’s transparent and equitable is the most sacrosanct assurance of safety we can provide research patients.
The FDA has released draft guidance regarding its position on early and efficient communications during drug development as a key way to reduce approval times between the agency and Investigational New Drug (IND) sponsors.
CW Weekly presents this feature as a way to put the spotlight on issues faced by executives in the clinical trial space. Staff writer Ron Rosenberg interviewed Piet van der Graaf, Pharm.D., Ph.D., vice president of quantitative systems pharmacology at Certara and former director of XenologiQ, a QSP consultancy.
A number of esteemed medical research institutions have routinely violated a federal law that requires public reporting of clinical study results.
Tetragenetics, an emerging biotechnology company engaged in the expression of ion channel drug targets, has announced a new partnership program for the discovery and development of therapeutic monoclonal antibodies (mAbs) directed against well-known ion channel drug targets implicated in a wide range of disease states—such as pain and autoimmune disorders.