Monitoring Drug Safety Information - Recommendations of Foreign Regulatory Authorities

Challenges to Data Monitoring Committees When Regulatory Authorities Intervene.

Improving drug safety monitoring.

Drug safety monitoring is important in children. Young age, polypharmacy, prolonged hospitaliza-tion, being critically ill and use of unlicensed and off-label drugs have been identified as risk factors which predispose a child to experience an adverse drug reaction. In our country, the HIV/AIDS epidemic, setting up of intensive care units, increasing availability of imaging studies, and the int...

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...

Monitoring and antiepileptic drug safety.

Treatment of patients with epilepsy strives for complete seizure control without intolerable drug side effects. Independent of blood drug levels, toxic effects allow titration to efficacy; however, allergic reactions, metabolically or genetically determined drug-induced illnesses, and idiosyncratic effects of drugs, while rare, may be life-threatening.Monitoring is an attempt to detect serious ...

Relationship between receiving authorities and monitoring authorities. The EMEA experience.

The approach of the European Medicines Agency (EMEA) to good laboratory practice (GLP) inspections in the context of authorization of medicinal products is illustrated with particular reference to the EMEA's experience as a receiving authority (RA), the procedures it has in place for the reporting and follow-up of GLP inspections, and the role of the ad hoc GLP inspectors working group. Other k...