The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a federal law enacted by Congress. Along with other federal laws, it establishes the legal framework within...

There is no doubt about the importance of maintaining quality standards throughout clinical research processes, but in recent years the regulatory bodies have begun t...

Small- to mid-sized (aka “emerging”) firms bring fewer resources to bear on the same drug development problems as large pharmaceutical companies. All developers face ...

Systemic lupus erythematosus (SLE) is an autoimmune disease that causes the immune system to produce several types of antibodies, particularly against cell nuclei. Th...

Advancements in technology are impacting many aspects of clinical research, opening doors to innovative study designs and clinical operations that may not have been p...