Tag Archive: FDA

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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Laws, Regulations, Guidances, Guidelines and Best Practices

Bart Cobert attempts to clear up the confusion around Drug Safety and PV requirements in different regions of the world, with a focus on US and EU requirements.

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AEs in Children

Drug Safety and AEs in Children

As the saying goes, children are not small adults. Thus the approach of pharmacovigilance to AEs in children needs to be different from that in adults.

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Remote PV Audits & Inpsections

Remote PV Audits & Inspections

The advantages and disadvantages of remote audits and inspections – also called virtual inspections, distant inspections, paper inspections, web inspections, and telephone inspections.

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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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CURES Act of 2016 and Drug Safety

A look at the somewhat controversial law was passed in late 2016 known as The 21st Century Cures Act - and its implications for drug safety.

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PMCs and PMRs

PMCs and PMRs: Some Good News

Bart Cobert looks at the recent FDA report on Post-Marketing Requirements (PMRs) and Post-Marketing Commitments (PMCs).

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Timely Reporting to the FDA

Bart Cobert examines 2 recent cases of late reporting of clinical trial information to the FDA and other federal agencies.

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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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The Experience Matters.

As an industry leader in business process outsourcing, C3i Solutions delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.

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