Drug master file authorization
FDA Office of Generic Drugs is correcting its April 8 update letter to all ANDA and AADA applicants ('The Pink Sheet" April 25, T&G-5). The letter stated that OGD requires an original signature on the letter of authorization from the DMF holder. "While OGD prefers an original signature in this instance, it will not refuse to file an application for failure to have this signature as an original," OGD said. Questions can be directed to the Regulatory Support Branch 301-594-0315
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