Drug Shortage Prevention Could Be Funded Through GDUFA
GPhA recommends FDA deploy user fee research money to look at shortage risk assessment and mitigation strategies, while the trade group continues to look for a product to fit its own shortage prediction model.
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If Drug Distributors Can Coordinate Without Anti-Trust Concerns During The Coronavirus Pandemic, What About Generic Manufacturers?
Experts and stakeholders suggest it may help avoid drug shortages, but also indicate the interaction, which in normal times would raise anti-trust concerns, may not be needed, even to fight coronavirus.
Director Uhl’s medical leave puts bioequivalence office head John Peters in the limelight.
FDA says it will need tools to evaluate technologies designed to deter nasal abuse in generics.