Tag Archive: adverse events

Does Rapid FDA Approval Produce Drug Safety Issues?

Bart Cobert gives his pharmacovigilance point of view on a recent paper on FDA approval timelines and drug safety issues.

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Guide to Causality Assessment

What information should be examined in the study and work up of ADRs to determine whether the reaction is likely due to the drug or not.

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Safety Reporting: Why We Do What We Do

We participate in safety reporting not only because it is required by law, but because we are HCPs whose first duty is always to protect the patient.

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Medical Monitoring 101

Medical Monitoring 101: Providing Medical Expertise for Clinical Trials

Exploring the role of the Medical Monitor in the clinical research process.

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FDA Adverse Events Reporting System (FAERS)

FDA operates one of the largest and most complete databases of adverse events on drugs marketed in the US. FAERS data is now easily searchable online.

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Online Drug Safety

Safety of Drugs Bought Abroad or Online

Many US patients are obtaining drugs from online and foreign pharmacies. Bart Cobert examines this trend, and its impact on drug safety.

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When Medical Information Becomes a Drug Safety Issue

Closely-tied Medical Information and Drug Safety departments, with a seamless adverse event intake and hand-off processs, offer better quality control, scalability and risk mitigation.

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Adverse Events: Not Just a Concern for Healthcare

Frank Pettinato discusses the FDA database which catalogs adverse event and product complaint info for foods, dietary supplements, and cosmetics.

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Pharma’s Practical Next Steps for Social Media

What’s Next: Practical Steps for Pharma's Increased Social Media Participation

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FDA’s Drug Safety Report

A look at FDA's recent drug safety report, which outlines their procedures in place to monitor drug safety, called Drug Safety Priorities. Initiatives & Innovation.

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