KS MPJE Review Latest Update Graded A+

KS MPJE Review Latest Update Graded A+ Pure Food and Drug Act of 1906 Focused on Purity and Quality Prohibited the interstate transfer of adulterated or misbranded drugs Recognized USP/NF Standards Food, Drug, and Cosmetic Act of 1938 Focused on Safety New drug cannot be marketed until proven safe (drugs prior to 1938 were exempt) Power given to Congress via authority over interstate commerce Durham-Humphrey Amendment of 1951 Established 2 classes of drugs: Rx and OTC Established provisions for dispensing prescription drugs Established labeling requirements for OTC and prescription drugs Established use of NDC numbers Labeling requirements for OTC Drugs "Adequate directions for use" Labeling requirements for Rx Drugs "Adequate information for use" Kefauver-Harris Amendments of 1962 Focused on safety AND efficacy Impacts all drugs after 1962 and new drugs with an NDA approved since 1938 Established effectiveness as a standard Established Good Manufacturing Practices (GMP) Transfered jurisdiction of Rx advertising from FTC to FDA Drug Efficacy Study Implementation (DESI) established ANDA process (abbreviated new drug application for generics) Deals with the efficacy of drugs marketed between Medical Device Amendment of 1976 Classification of all devices into 3 classes based on the degree of control necessary to assue safety and effectiveness; most regulated are class 3 Class 3 Medical Device one that supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury New Drug Application (NDA) Used if new drug is a newly discovered chemical or for an established drug offered in a new dosage form, with ne therapeutic claims, in new dosage levels, or for a different patient population Abbreviated New Drug Application (ANDA) approval to market a generic IND investigational new drug Supplemental New Drug Application (sNDA) application to allow a company to make changes to a product that already has an approved NDA. CDER must approve all changes to ensure that conditions originally set for the product are still met FDA Clinical Trials Phase 1 Small number of patients (20-80) Evaluates safety Determines safe dosage range Identifies side effects FDA Clinical Trials Phase 2 Small number of patients with condition (100-300) Establishes testing protocol Establishes if drug is effective Further evaluates safety FDA Clinical Trials Phase 3 patients in a clinical setting Usually double-blinded Confirms effectiveness Monitors side effects Compares to commonly used treatments FDA Clinical