Monitoring for Adverse Events Post Marketing Approval of a Drug
نویسندگان
چکیده
منابع مشابه
Drug Safety Unscrambling Post - Approval Drug Safety Monitoring
Among the thorny issues confronting newlyconfirmed FDA Commissioner Gottlieb is the unresolved rulemaking proposal to permit generic drug manufacturers to amend safety warnings in their labels without prior FDA approval. At present, only pioneer branded manufacturers holding New Drug Applications may make such amendments to respond to newlydiscovered evidence of a reasonable association between...
متن کاملChoosing appropriate theories for understanding hospital reporting of adverse drug events, a theoretical domains framework approach
Adverse drug events (ADEs) may cause serious injuries including death. Spontaneous reporting of ADEs plays a great role in detection and prevention of them, however, underreporting always exists. Although several interventions have been utilized to solve this problem, they are mainly based on experience and the rationale for choosing them has no theoretical base. The vast variety of behavioral ...
متن کاملChoosing appropriate theories for understanding hospital reporting of adverse drug events, a theoretical domains framework approach
Adverse drug events (ADEs) may cause serious injuries including death. Spontaneous reporting of ADEs plays a great role in detection and prevention of them, however, underreporting always exists. Although several interventions have been utilized to solve this problem, they are mainly based on experience and the rationale for choosing them has no theoretical base. The vast variety of behavioral ...
متن کاملDecision support methods for the detection of adverse events in post-marketing data.
Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical meas...
متن کاملWeight and consequences of post-marketing (-approval) experience.
In the European Union the term pharmacovigilance is normally used to describe post-marketing or, more precisely, post-approval experience after the regulatory approval of drugs and their introduction to the market under defined conditions. The term describes activities used to gather information on the effects of medicinal products, with emphasis on those aspects which have not, or could not ha...
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ژورنال
عنوان ژورنال: International Journal of Allergy Medications
سال: 2015
ISSN: 2572-3308
DOI: 10.23937/2572-3308.1510010