Day: November 10, 2022

A joint report of the review of internal processes at the FDA for the Breakthrough Therapy Designation (BTD), and at the European Medicines Agency (EMA) for its breakthrough drug program called the Priority Medicines (PRIME), shows that the two agencies when presented with the same data for a product, interpreted in an opposite manner about … Read more

An antiquated FDA policy prohibits collection of tissues, cells, organs, and blood from gay donors and sub-Saharan African immigrants. These prohibitions apply even if vigorous testing shows these donors to be non-infectious and healthy. These prohibitions are enforced by the FDA through improper means via its Guidance Documents and not through the appropriate regulatory process. … Read more