Laws answer passe - Study guides, Class notes & Summaries

Laws - ANSWER passed by national legislative bodies; establish authority of national regulatory body Regulations - ANSWER Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - ANSWER "current thinking" of regulatory bodies; non-binding ICH - ANSWER Developed to keep people doing things the same way across the world; international effort to harmonize the technical requirements for product registration SOPs - ANSW...