Blog

EMA revising pediatric wavier forms

Many companies are hesitant to perform clinical studies on children due to the risks and ethical issues that can arise. This is why the European Medicines Agency (EMA) is looking into revising and reforming the product class waivers to allow companies to test new...

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New report done by EMA finds deficiencies in GCP’s

A recent report done by the European Medicines Agency (EMA) on good clinical procedures (GCP) found there were deficiencies around standard operation practices (SOPs). These deficiencies were found in monitoring, data management, and other documents for trials done in...

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21st Century Cares Act gets passed by Congress

The 21st Century Cares Act was passed with an overwhelming majority on July 10th, 2015. This bill would increase the funding for both the NIH and FDA and instate a new framework for evaluating patience’s experience with drugs risks and benefits. Not only will the bill...

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Does the US need to invest more in biomedical research?

According to a recent article by Senator Amy Klobuchar, the United States has always been the world leader when it comes to biomedical research and innovation. However, many other countries are starting to rapidly catch up, and the United States may need to put more...

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