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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.

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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.

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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 Proposes Guidance On Notifying FDA Of A Permanent Discontinuance Or Interruption In Manufacturing Of A Medical Device

The FDA's draft guidance, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the.

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2022 Food and Drug Newsletter - January 2022 | Arnall Golden Gregory LLP

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our.

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