Alabama Pharmacy Defense Attorney – Hearing Defense – FDA to Approve Generics Based on Draft Labeling

1806_Graphic-Image_PinteresAlabama Pharmacy Defense Attorney – Hearing Defense – FDA to Approve Generics Based on Draft Labeling – (866) 348-2889

The FDA’s Office of Generic Drugs (OGD) will no longer require final printed labeling to approve Abbreviated New Drug Applications (ANDAs).

Instead, the FDA will approve ANDAs on the basis of draft labeling, provided that the draft version enables OGD to conduct an appropriate review before a final printed label for a pending generic drug is produced.

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