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March 18, 2025

Laboratory Methods (Drugs)

Listed below are analytical laboratory methods developed and used by FDA to test certain drug quality attributes that also may impact safety. These FDA testing methods […]
March 17, 2025

ProRx, LLC – 696742 – 03/04/2025

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Mr. Mark L’Hommedieu Recipient Title Managing Partner ProRx, LLC 619 […]
March 14, 2025

CDER – Biological Product Deviations

To facilitate Biological Product Deviation (BPD) reporting, FDA has developed a standardized reporting form that may be submitted electronically via e-mail or in paper format by […]
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