Saudi FDA Consults On Compassionate Use Program Requirements
The Saudi drug authority has clarified the roles and responsibilities of the various players involved with giving patients access to drugs under development on compassionate grounds.
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A new agreement signed between Singapore’s Health Sciences Authority and South Korea’s Ministry of Food and Drug Safety means drug manufacturers in the two regions will be subjected to fewer duplicative good manufacturing practice inspections.
The European Medicines Agency has issued a “letter of support” to encourage ongoing efforts by an industry-led consortium to establish measurable residual disease as a surrogate efficacy endpoint in clinical studies of patients with acute myeloid leukemia.