FDA guidance clarifies requirements for reporting drug shortages, building on pandemic-era approach

Today, FDA published a new draft version of a COVID-19-era final guidance that details when and how sponsors should notify FDA of supply chain disruptions or discontinuances that will impact the domestic availability of certain products. Though many of the recommendations have long been in practice, the draft also provides some long-awaited details on how the Agency expects sponsors to notify FDA about API shortages that are anticipated to impact the downstream availability of finished products.


Drug shortages are a serious public health concern that reached a crisis level in the early 2010s.

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