Tag Archive: FDA

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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Monitoring Medical Literature for Drug Safety

Monitoring of medical literature for safety signals and adverse events is critical to both veterinary and human PV.

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FDA Guidance on Biosimilar Labeling

Bart Cobert reviews the newly published FDA draft guidance for industry on Labeling for Biosimilar Products.

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Animal Health 101: Key Components of a Veterinary PV Program

As in the human medical sciences field, the world of veterinary PV is constantly evolving. Explore the 4 main components of an animal health PV program.

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IND Safety Reporting

FDA’s Safety Assessment for IND Safety Reporting Draft Guidance

Bart Cobert examine's the FDA's latest guidance on Safety Assessment for IND Safety Reporting

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FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development – Safety

Bart Cobert reviews the FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development, and how it relates to safety.

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SAE Reporting for Outsourcing Facilities (Compounders)

Bart Cobert reviews the FDA guidance on AE Reporting for Outsourcing Facilities (Compounders)

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Bart’s Corner: Preparing and Coding Expedited Reports

In my thirty years in this business doing both medical and operational drug safety and pharmacovigilance, I’ve seen that just about every possible permutation of handling expedited reports has been used. In many cases, it does not matter how such reports are handled and most of the different methods work[…]

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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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