The US FDA (Food and drug administration) is in charge of upholding patients and defending public health by guarantee the safety, security of medications, and efficacy. In order to achieve safety, the FDA’s major monitoring method is preventing adverse drug events, which happen with promoted drugs is the adverse event reporting system (AERS). The FDA defines an adverse event as any undesirable experience connected with the use of a therapeutic product. It is mainly focused on serious adverse…

The current Good Clinical Practices (cGCP) have their origin in 1964, wherein the 18th World Medical Association Annual General Assembly voted to adopt the Declaration of Helsinki. The primary objective of the Declaration of Helsinki is assuring the safety and wellbeing of each medical trial subject. Since that 1964 adoption vote, the cGCPs have been harmonized, globally required by Regulatory Bodies, and the America Association of Medical Assistants (AAMA).

A successful Clinical…