Civica, Mayo Clinic and others sound off on FDA draft guidance to mitigate drug shortages
Several pharma groups are laying out the positives and negatives of new FDA draft guidance on how best to handle drug shortages.
The draft is intended to help companies develop and implement risk management plans (RMPs) to assist with any shortages of drugs or biologics. The guidance recommends a framework and factors for stakeholders to develop RMPs for their establishments, API manufacturers and others.
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