FDA has released a new final guidance document supporting clinical studies of new medical devices under their Investigational Device Exemption (IDE) regulations. In order to conduct clinical trials on investigational products, medical device companies must submit an...
After sixteen years FDA has released a new draft guidance with updated regulations concerning the obtainment of informed consent from clinical trial subjects.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...
FDA has issued final guidance concerning the transfer of clinical studies between IRBs. According to Zachary Brennan on www.outsourcing-pharma.com, FDA says the transfer process “should be accomplished in a way that assures continuous IRB oversight with no lapse in...
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Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring,” issued early August is similar to the draft guidance published in 2011.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...
