MPJE Law Review Questions with 100% Correct Answers | Verified | Latest Update 2024| Rated A+

MPJE Law Review Questions with 100% Correct Answers | Verified | Latest Update 2024| Rated A+ 1951: Durham-Humphrey amendments - 1) 2 classes of drugs (RX vs OTC) 2) authorized verbal rx and rx refills 1962: Kefauver-Harris amendments - safety and efficacy requirements 1984: Drug Price Competition and Patent Term Restoration Act - ANDA (abreviated new drug application) for generics 1987: PDMA (precription drug marketing act) - 1) cant sell/purchase/trade Rx samples 2) bands re-importation of drugs 1997: FDA Modernization Act - 1) change legend to "Rx only" 2) clarify compounding vs manufacturing 3) speeds review of 'new' products 2007: FDAAA - 1) REMS (risk evaluation and mitagation strategies 2) Required side effects toll free number statement Adulteration - Define: incorrect purity, cleanliness and strength Misbranding - 1) false or misleading 2) failure to have req'd info on rx label Adulteration vs. Misbranding: incorrect strength dispensed - adulteration