KS MPJE Review
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 1938-1962
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
1000-3000 patients in a clinical setting
Usually double-blinded
Confirms effectiveness
Monitors side effects
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 1938-1962
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
1000-3000 patients in a clinical setting
Usually double-blinded
Confirms effectiveness
Monitors side effects
