Flagship’s Foghorn, in partnership with Merck and Eli Lilly, obtains partial support from the FDA after the death of a patient


Because the majority of drug shortages are still associated with manufacturing-related quality issues, the FDA on Thursday released new draft guidance on how to proactively assess risks to manufacturing processes and supply chains, while understanding market vulnerabilities.

While drug shortages peaked in 2011, the FDA says in its new 18-page draft guidance that the number of new drug shortages “has declined significantly since” that peak, bottoming out in 2015 and 2016, in part. through the enactment of a new law. , known as FDASIA, which helped the agency better prevent or mitigate drug supply disruptions and shortages, and clarified cGMP requirements.


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