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FDA Issues Important Guidance Documents On Drug Risk Management Plans And Out-of-Specification Test Results - Healthcare

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

FDA Finds Drug Shortages Are Mostly Caused By Quality Issues

A new FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages follows on the heels of a 2020 FDA task force report.

Peterh calcottDrug shortages taskDrug administration safetyTask force report on drug shortagesHuman servicesPublic health servicesCalcott consultingEffective quality risk management program outsourced pharmaInnovation actPermanent discontinuanceForce report on drugRisk management plansRisk management planRole of intuition when makingIndustry marchManagement plans

FDA Finds Drug Shortages Are Mostly Caused By Quality Issues

A new FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages follows on the heels of a 2020 FDA task force report.

Peterh calcottDrug shortages taskDrug administration safetyTask force report on drug shortagesHuman servicesPublic health servicesCalcott consultingEffective quality risk management program outsourced pharmaInnovation actPermanent discontinuanceForce report on drugRisk management plansRisk management planRole of intuition when makingIndustry marchManagement plans

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