In response to FDA’s recent draft guidance on informed consent, industry affiliates such as the Association of Clinical Research Organizations (ACRO) and the Dana Farber Cancer Institute have provided detailed feedback in anticipation of the final guidance....
After sixteen years FDA has released a new draft guidance with updated regulations concerning the obtainment of informed consent from clinical trial subjects. The guidance begins by reiterating the basic process for obtaining consent, beyond written documentation. FDA...
Pharmalive.com’s Ed Silverman reports that in another attempt to stop the European Medicines Agency (EMA) from continuing with their new policy for trial data disclosure, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has openly...
The final FDA guidance entitled “Guidance for Industry Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring,” issued early August is similar to the draft guidance published in 2011. FDA encourages risk based remote monitoring,...
