Since the beginning of 2018, there has been a growing interest from pharmaceutical and biotech firms in the United States regarding the basic tenets of the European Union’s (EU) new General Data Protections Regulation (GDPR) law. With more than 50 percent of all...
In July 2019, the European Union (EU) Clinical Trial Regulation No. 536/2014 will go into effect, requiring all sponsors, including academia, conducting clinical trials to draft lay or plain language summaries for phase 2-4 clinical trials. These lay summaries need to...
A room full of statisticians and clinical programmers were floored to hear that regulatory operations experts were working with nearly 500,000 pages of text in a recent New Drug Application (NDA). This is how Mary Anne Potok, Technical Manager, Regulatory Operations,...
The Food and Drug Administration’s (FDA) drug approval process puts patient health at the forefront and subjects each new drug candidate to several stages of testing in both preclinical and clinical settings. This rigorous process typically requires 10 years or more...
The FDA provided insight into their overall vision for clinical trial transparency last week, announcing a new program to publicly release clinical study reports (CSRs) that accompany drug approval submissions. They plan to pilot nine recently-approved drugs (yet to...
Bioethics International recently published their second, long-promised Good Pharma Scorecard, a ranking of large biopharmaceutical companies’ compliance with disclosing data for new medicines to public registries, in BMJ Open. With this recent publication, a spotlight...
In the United States, the number of patients with Alzheimer’s disease is projected to increase from the current prevalence of around 5.5 million to around 14 million in 2050. These sobering numbers reflect an urgent need for increased awareness and proactive decision...
In an effort to give back to our community, MMS colleagues worked with the American Red Cross to deliver water to our neighbors in Flint, Michigan. On Wednesday, March 9, the MMS team was able to deliver 190 cases of water and numerous water filters to over 140 homes....