The Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) provides compliance information regarding the U.S. Food and Drug Administration’s (FDA) guidelines on electronic records and electronic signatures. Within this part, requirements are…

The amendment was a response to the Thalidomide tragedy, in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness…

Unlike generic medicines where the active ingredients are identical, biosimilars – by definition – are not likely to be identical to the originator biologic. They are similar, but not the…

A radiopharmaceutical is a radioactive pharmaceutical agent that is used for diagnostic or therapeutic procedures. For a product to be classified as a radiopharmaceutical agent safe for human use, the…

In the United States, the Food and Drug Administration (FDA) regulates the development of new drug products and their subsequent marketing. One of the FDA’s functions is to promote and…