FDA Expedites Reviews Of Alternatives To Puerto Rico Drugs In Shortage

October 13, 2017 at 5:31 PM
FDA announced Friday (Oct. 13) that it is expediting reviews and approvals of alternative dosage forms and generic versions of multiple critical drugs facing shortages following the hurricane in Puerto Rico. An FDA spokesperson tells Inside Health Policy the expedited reviews are being conducted for multiple manufacturers, but declined to comment on which manufacturers are being assisted. Expedited review may be granted to “submissions that could help mitigate or resolve a drug shortage and prevent future shortages, including submissions...

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