Beginning March 7, 2012, the Food and Drug Administration will require new language in all consent forms for drug or device clinical trials that are initiated on or after that date.

The National Institute of Allergy and Infectious Diseases and the National Institute of Mental Health, National Institutes of Health, invite applications for Beyond HAART:  Innovative Therapies to Control HIV-1.  This initiative will support project applications to develop therapeutic approaches that could allow HIV-1 infected persons to discontinue current HIV-1 treatments for a sustained period without […]

The Clinical and Translational Science Institute (CTSI) helps investigators register clinical trials to ensure regulatory compliance and to prepare for publication of results. Although the Food and Drug Administration requires registration for certain trials involving drugs, biologics, and devices, the International Committee of Medical Journal Editors requires public registry of all clinical trials before publication. […]

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the […]

Presentations will by offered by the Minnesota North Central Regional chapter of the Society of Clinical Research Associates on Tuesday, September 21, 2010, from 3:00-7:30 p.m. Topics and presenters include: Timothy Philips, B.S. Compliance Officer/Biomedical Engineer, FDA – Minneapolis District FDA Operations, Inspections, and Enforcement Learning Objectives:  At the end of this presentation, attendees should […]