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Regulatory Focus™ > News Articles > Global Access to Medicinal Products: Compassionate Use Procedures

Global Access to Medicinal Products: Compassionate Use Procedures

Posted 01 January 2010

In most developed countries, regulation of new human medicinal products is based on confirmation of their safety and effectiveness before they are distributed commercially for use in treating patients. These laws and regulations, and the agencies that enforce them, evolved throughout the 20th century. Changes were periodically driven forward by public health crises that involved serious and severe adverse drug reactions, such as the deaths caused by elixir of sulfanilamide in 1937 and, in 1962, the birth defects in babies of mothers who were administered thalidomide. These events elicited broad support for stronger regulation to protect the public from drugs that were inadequately studied, and thus potentially dangerous.


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