Category Archives: Safety

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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60 Years of Pharma Regulation in Europe

European regulation of pharmaceuticals has, since the foundation of the European Union around 60 years ago, been a story of medicines being controlled in a collaboration between regulators at the EU and national levels. In recent years, this collaboration has been extended to involve not just the regulators themselves but also other stakeholders such as […]
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Grant for Counterfeit Drug Detecting Device

PharmaChk, a portable anticounterfeiting device, has received a $2 million transition-to-scale grant from Saving Lives at Birth: A Grand Challenge for Development. PharmaChk is being developed in conjunction with researchers at Boston University (BU) to detect and quantify active ingredients in medicines.
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