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FDA published Video about OFM

The U.S. Food and Drug Administration recently published a video showing the potential of dermal open-flow microperfusion (dOFM) for generic drug development.

Credit: FDA, JOANNEUM RESEARCH

FDA approval for most topical generic drugs requires a clinical endpoint study to compare the therapeutic effect with the original product. JOANNEUM RESEARCH HEALTH has developed a new method and strategy (dOFM) to apply for the approval of generic drugs without the need of a clinical endpoint study. Now, the FDA has released a short video illustrating the use of dOFM to evaluate bioequivalence for topical drugs.

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