Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not...
In order to present related information to a clinical study and acquire and document informed consent, electronic systems and processes such as text, audio, and graphics are increasingly being employed. According to FDA per their new draft guidance, this is referred...
After sixteen years FDA has released a new draft guidance with updated regulations concerning the obtainment of informed consent from clinical trial subjects.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...
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Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring,” issued early August is similar to the draft guidance published in 2011.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,...
FDA released a new guidance today that reflects items that have appeared across several past guidance documents. It is entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for...
