Abstract The Regulation and approval process of medical devices are different from regulation and approval process of medicinal products. For instance, in the US, medical devices are regulated by the… read more →
Abstract Pharmaceutical products are not limited to therapeutic drugs and biologics. These pharmaceutical products are regulated by different branches of medicinal product’s regulatory agency. In the US, the center for… read more →
The establishment of medicinal regulatory agency’s intent is in facilitating and protecting public health interest by ensuring the safety and efficacy evaluation of medicinal products (biologics, devices, drugs) and other… read more →
Innovations or inventions have many mothering factors. One of the major enticing factor is profitable societal and unmet needs. There are also altruism and noble causes driven by the optimism… read more →
The Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) is an emerging disease prevalent in the Eastern province of Middle East. The disease was first reported in September 2012 and it has… read more →
Protein infectious particles are proteins called “Prions” that causes brain and neurological diseases in animals and humans. For so many years, scientists classified most foodborne disease causing agents as chemical,… read more →
The growth of technology and data standards has affected data management standards of clinical research in several ways. The most important aspect of standards is the ability to maintain data… read more →
Abstract The Oracle, ePharma Solutions, and Perceptive Informatics applies integrated and accessible EDC systems in pharmaceutical clinical trial’s data capture. However, Medidata Rave has become one of the major electronic… read more →
The best clinical practice in any clinical study is ensuring the safety of human subjects while enhancing scientific knowledge. Such scientific principle holds any clinical regulations and guidelines to the… read more →
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