Without qualified legal counsel, the number of regulatory procedures to follow can be intimidating and it is almost impossible to know which legal options are viable. (harrellandharrell.com)
With two distinct organisations taking over the monitoring of regulatory procedures, different reporting skills are expected to be required for each. (social.hays.com)
But, this type of study is not always used when testing new medical products for FDA approval, and it is particularly rare for new devices, which are subject to different regulatory procedures from prescription drugs. (aaas.org)