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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