GPhA’s Drug Shortage Initiative Clears FTC Hurdle; Still Working With FDA
This article was originally published in The Gold Sheet
Five manufacturers have agreed to give IMS Health production and supply information about drugs in short supply; GPhA and IMS are working with FDA to finalize the details of the accelerated recovery initiative.
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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.
The heavily concentrated sterile injectable manufacturing industry is creating roadblocks to the success of the Accelerated Recovery Initiative; GPhA predicts crisis will linger for years to come.
A UK MHRA official said there is a “regulatory dilemma” between meeting GMP enforcement obligations and preventing drug shortages. New changes in the EU GMP Guide aim to take a more proactive approach to drug shortages by requiring early notification by manufacturers, while in the U.S. a new drug shortage prevention program called the Accelerated Recovery Initiative (ARI) is finally getting off the ground.