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20

Mag

FDA - Risk Management Plans to Mitigate the Potential for Drug Shortages

Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to fewer new drug shortages and reduced the time to resolve existing drug shortages. This is due, in part, to authorities the agency now has, including those added by the Food and Drug Administration Safety and Innovation Act.

But despite mitigating or preventing hundreds of new drug shortages, disruptions in the U.S. drug supply continue to occur due to drug quality problems, vulnerabilities in the global supply chain, unanticipated increases in demand, market withdrawals of drugs or natural disasters.

In 2019, in an effort to address the national drug shortage problem, the federal Drug Shortages Task Force released a report that called for the adoption of risk management plans to proactively assess risk and to predict and prevent supply disruptions that could potentially lead to a drug shortage. Then in 2020, Congress passed the CARES Act to require certain manufacturers to develop, maintain, and implement, as appropriate, risk management plans that identify and evaluate risks to a drug’s supply.

To further assist manufacturers with these requirements, we are issuing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, intended to help with the development, maintenance and implementation of risk management plans. [FDA]

19

Mag

US Generic Drug User Fee

Assessing User Fees Under the Generic Drug User Fee Amendments of 2017



This guidance...

16

Mag

EMA public consultation - Remote QP Batch Certification

Stakeholders given one month to weigh in on proposal to allow relaxations introduced in response to...

16

Mag

Farmaci generici. In quattro anni il mercato potrebbe andare oltre i 507 miliardi di dollari

A prevalere sarà l'uso di farmaci per le malattie croniche, soprattutto nel campo cardiovascolare...

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