FDA Looks To Expedite Generic Drug Approvals


In the past several days, the FDA has released a host of guidance documents. They’ve continued that trend with a new guidance to help generic drug companies quicken the pace of generic drug approvals. The FDA guidance has indicated a shift in stance. The FDA “now will approve a generic drug for which it has made a final determination that the [reference listed drug] RLD was not withdrawn from sale for safety or effectiveness reasons even if that determination has not yet published in the Federal Register, and will proceed with Federal Register publication as expeditiously as is practicable,” the guidance read.

Read the source article at RAPS.org

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