FDA issues draft guidance aimed at curbing manufacturing shortages
The FDA is hoping that its latest draft guidance will lead to better information about potential drug and active pharmaceutical ingredient (API) shortages from manufacturers.
The proposed draft guidance aims to paint a clearer picture for manufacturers about giving notifications for changes in the production of drugs, biological products or APIs, the FDA said in the 17-page document. The move comes as the FDA works to prevent and manage drug shortages.
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