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FDA Shortage Notification Mandate May Not Extend To Biologics

 
• By Derrick Gingery

The agency has the option to issue regulations requiring biologics manufacturers to notify FDA of emerging production problems, but so far it’s only “something that we’re thinking about.”

FDA is still considering whether to extend its oversight powers regarding drug shortage mitigation requirements to biologics as well.

Douglas Throckmorton, deputy director of the Center for Drug Evaluation and Research, said the agency has a track record of doing whatever is necessary to maintain patient access to drugs,...

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