Category Archives: Safety

European Pharma: Paying the Price of Pharmacovigilance

Pharmacovigilance controls are becoming firmly embedded in the European Union’s post-authorization regulatory system, with the European Medicines Agency (EMA) acting as the pivot for an EU-wide network of agencies monitoring medicines throughout their market lifespan. The new pharmacovigilance activities stemming from the EU legislation, the first stage of which was approved four years ago, relate […]
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EFPIA Efforts to Block Stolen Drugs in European Supply Chain

The European Federation of Pharmaceutical Industries and Associations’ new medicines verification system will put an end to the re-sale of stolen and counterfeit drugs in the European supply chain, the organisation claims. The European Stakeholder Model (ESM) reportedly offers a cost-effective technological solution using anti-tampering device together with 2D barcoding to verify the authenticity of medicinal products. Because of loopholes […]
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USP Analytical Research Award Winners 2014

An international group of three scientists are the recipients of United States Pharmacopeial Convention’s 2014–2015 Global Fellowship Awards, aimed at advancing research involving quality standards for medicines. The recipients’ research will involve analytical tools useful in researching the safety of biopharmaceutical drugs, the detection of substandard drugs in the developing world, and the quality of dry […]
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Implementing the Generic Drug User Fee Act: Struggles and Successes

Two years into the Generic Drug User Fee Act (GDUFA) program, enacted in July 2012, FDA officials are striving to meet goals and timelines for speeding new generic drugs to market. Agency reviewers have made some progress in eliminating the huge backlog in abbreviated new drug applications (ANDAs) pending in the Office of Generic Drugs […]
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Ebola Outbreak Raises Ethical Issues

The development of new treatments and preventives to combat the lethal Ebola virus has been slow, marked by caution at public health agencies to approve testing of high-risk compounds, and reluctance of biopharmaceutical companies to invest in a field with limited market potential. All that has changed now, as thousands of people have been sickened […]
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