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Select Updates for the 506J Guidance: 506J Device List and Additional Notifications

Select updates for the 506J Guidance: proposed list of devices requiring 506J notification and clarification as to the submission of voluntary notifications ....

Radiological Health , Guidance Issuing Office , Drug Administration , Submit Comments , Biologics Evaluation , Permanent Discontinuance , Device Under Section ,

FDA Issues New Guidance On Discontinuance Or Interruption In Manufacturing Of Finished Products Or APIs

In April 2023, the FDA issued an updated guidance superseding and replacing the previous 2020 document about managing drug shortages and explaining. ....

Peterh Calcott , Calcott Consulting , National Drug Code , Field Alerts , Biological Product Deviation Reports , Permanent Discontinuance ,