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In May 2022, the US Food and Drug Administration (FDA), released two important guidance documents: Risk Management Plans to Mitigate the Potential for Drug Shortages Guidance for Industry.

Public health serviceDevelopment strategyDrug administrationRisk management plansDrug shortages guidanceInvestigating out of specificationTest resultsManagement plansShortages guidanceRequired productsActive pharmaceutical ingredientRisk communicationManagement toolsProduction guidanceStability dataAlert report submission questions