FDA rules for clinical studies of drugs and biologics
When an IND is required under 21 CFR Part 312, the exemptions, and the informed consent and investigator duties that govern FDA-regulated drug trials.
Tag: clinical
3 posts
EU rules for clinical studies of medical devices
How Regulation (EU) 2017/745 governs clinical investigations of medical devices, which studies it covers and when authorisation or notification is needed.
FDA rules for clinical studies of medical devices
How 21 CFR parts 812, 50 and 56 govern clinical investigations of medical devices, including when an IDE application must be submitted to FDA.