Does a clinical investigation involving a marketed product require IRB review and approval?

Yes, if the investigation is governed by FDA regulations see 21 CFR 56.101, 56.102(c), 312.2(b)(1), 361.1, 601.2, and 812.2. Also, see the information sheet entitled " 'Off-label' and Investigational Use of Marketed Drugs and Biologics" for more information.

I cant really gove you an answer,but what I can give you is a way to a solution, that is you have to find the anglde that you relate to or peaks your interest. A good paper is one that people get drawn into because it reaches them ln some way.As for me WW11 to me, I think of the holocaust and the effect it had on the survivors, their families and those who stood by and did nothing until it was too late.

Related Questions