Tag Archive: FDA

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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FDA Draft Guidance on PMRs

Bart Cobert highlights the most important changes in the recently revised FDA draft guidance on PMRs.

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Importing Canadian Drugs to the US

Bart Cobert covers several issues involved in setting up the proposed "Safe Importation Plan" which aims to allow US consumers to get safe and cheaper drugs.

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Different Regulatory Actions from Different Agencies

Bart Cobert explores the potential reasons for the differing regulatory actions from the different agencies.

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Medical Marijuana and Drug Safety

Bart Cobert addresses the use of marijuana for medical purposes and the implications for Drug Safety.

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Patient Centricity in Clinical Trials

Patient engagement technology is critical to the needs of the pharmaceutical industry, and thus, patient centric clinical trials are the way forward.

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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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Language and Translations in PV

Pharmacovigilance expert Bart Cobert examines the issues associated with language translation in PV and drug safety.

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DMCs and SACs

Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).

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Data Security, Protection and the US-EU Privacy Shield: Part 2

Data Security, Protection and the US-EU Privacy Shield: Part 2

Bart Cobert reviews the key requirements for the US-EU Privacy Shield, including implications for US Firms, Pharma Companies, and Drug Safety & Pharmacovigilance

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