Tag Archive
The following is a list of all entries tagged with clinical development:
Liver Toxicity, FDA DILI Regulations Require Interpretation
Filed in clinical, pre-clinical, report, November 20, 2009, 5:15 pmSigns of liver toxicity from experimental results can mean that a project is killed or investors walk away, but this is often an inappropriate response. Liver toxicity is a highly complex issue and in an attempt to provide some light on the issue the FDA has recently published guidelines on Drug Induced Liver Injury (DILI). These guidelines set the regulatory standard and take a very pragmatic position on livertox and encourage industry to likewise take a pragmatic view.
Drug Development Guidance – FDA publish Drug Induced Livery Injust Evaluation Guidance
Filed in clinical, regulatory, August 19, 2009, 2:05 pmFDA publishes Drug-Induced Liver Injury: Premarketing Clinical Evaluation Guidance; his guidance is intended to assist the pharmaceutical industry and other investigators who are conducting new drug development in assessing the potential for a drug to cause severe liver injury (i.e., irreversible liver failure that is fatal or requires liver transplantation).
FDA introduces new Rules of IRB Registration
Filed in clinical, regulatory, July 23, 2009, 9:34 amThe FDA IRB Registration Rule is effective Tuesday, July 14, 2009. All IRBs reviewing FDA-regulated research must register between July 14 and September 14, 2009.
The Impact of the Clinical Trails Directive
Filed in clinical, regulatory, July 6, 2009, 9:01 amThe impact of the clinical trials directice on clinical drug development has been evaluated by ICREL (Impact of Clinical Research of European Legislation) who have just published their report (HEALTH-F1-2007-201002)
A Thought Provoking Consideration of Surrogate Endpoints
Filed in clinical, regulatory, May 19, 2009, 2:38 pmSurrogate endpoints are an essential part of the drug development professionals arsnel, without them many products would be too expensive and too long to be economicaly viable,
Entries