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Managed access program

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These regulatory programs are put in place on a country-by-country basis and can vary significantly across markets.[1]

Geographic Differences

In the United States, the Food and Drug Administration (FDA) has sanctioned expanded access programs, which provide access to investigational drugs, since 1987. This access is typically offered in later stages of development, after earlier studies have established a relatively high degree of certainty in safety and effectiveness.[2][3]

Notes

  1. ^ Sou, Hélène (August 2010). "EU Compassionate Use Programmes (CUPs): Regulatory Framework and Points to Consider before CUP Implementation". Pharmaceutical Medicine. 24 (4): 223–229. doi:10.1007/BF03256820.
  2. ^ "US National Cancer Institute - Access to Investigational Drugs".
  3. ^ "FDA New Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs".
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