Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness

Drug Safety

Volumn 38, Issue 10, 2015, Pages 849-853

  Kesselheim, Aaron S ^a   Gagne, Joshua J ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACARBOSE; ENOXAPARIN; FERRIC GLUCONATE; GENERIC DRUG; NOSE SPRAY; SALCATONIN; VANCOMYCIN; VENLAFAXINE;

BIOEQUIVALENCE; DRUG EFFICACY; DRUG SAFETY; EDITORIAL; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; MICROCAPSULE; PATIENT MONITORING; PHARMACEUTICAL EQUIVALENCE; PRIORITY JOURNAL; THERAPEUTIC EQUIVALENCE; UNITED STATES; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG COST; LEGISLATION AND JURISPRUDENCE; SAFETY;

CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG COSTS; DRUGS, GENERIC; ENOXAPARIN; FOLLOW-UP STUDIES; HUMANS; SAFETY; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84942368810     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-015-0315-7     Document Type: Editorial

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