What’s more, these simple, common sense requirements will help to ensure that a “good guy with a gun” is well regulated. These suggestions in no way violate anyone’s constitutional rights. When someone is caught driving illegally and we take away their license and/or their car do we c...
for items or services), not the FDA—an agency with a separate statutory purpose and agenda. Further, as the Secretary concedes, FDA approval is required even for investigational use under an IDE, and the requirements for FDA approval of an IDE do address the safety and efficacy of the ...