Breakthrough Therapy Designations
Listing of all ‘breakthrough’ drugs, including status and basis of designation. Updated weekly.
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Requiring that certain chemistry, manufacturing and controls conditions be satisfied before awarding breakthrough or regenerative medicine advanced therapy status would help ensure that the quality side of product development keeps pace with the clinical side, says Parexel's Mo Heidaran, a former CMC reviewer in the FDA’s biologics center.
Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker