Perspective

Regulatory professionals have the opportunity to work in unique situations and the desire to share their experiences so others can benefit. Perspective offers an insider’s eye into the workings of the regulatory profession.

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16 April 2013

Drug Reimportation: Is It the Solution to the High Cost of Prescription Drugs in the US?

By Atara Noiade, DOM, EAMP

Demand in the US for less-expensive pharmaceuticals has accelerated the controversial and illegal practice of drug reimportation by entities in other countries, whereby US-manufactured drugs, having been exported, are resold back to US consumers. Although reimportation gives people the opportunity to purchase pharmaceutical products at a significantly lower cost, reimported drugs, as well as those purchased online from other countries, currently have no guarantee of safety and may actually be expired or adulterated. Legislation of one aspect of drug reimportation, which would permit individuals to obtain their personal prescriptions via US-approved online foreign pharmacies, may provide a solution to the demand for less-expensive pharmaceuticals while ensuring their quality. [Read More...]


16 April 2012

A Closer Look at Strategic Alliances Between Drugmakers and CROs

By Diane R. Whitworth, MLS

Alliances between the pharmaceutical industry and contract research organizations (CROs) have evolved over the past three decades from transaction-based relationships to truly collaborative strategic partnerships. Although the traditional fee-for-service outsourcing model still exists, an increasing number of pharmaceutical companies and CROs have formed enduring partnerships. [Read More...]


16 April 2012

Perspective: A Modern Progressive Approval System for Rare Diseases

By Marc Dunoyer

The recent dramatic increase in the number of orphan drug designations has prompted patient groups, pharmaceutical companies, legislators and many other stakeholders to look for ways to accelerate the delivery of innovative new medicines to people with rare diseases. In particular, patients suffering from illnesses for which there are no adequate licensed therapies want access to promising new products earlier in the drug development cycle. [Read More...]


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