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Feb 72 min read

USFDA Guidance: "Understanding the USFDA Notification Process for Discontinuance or Interruption in Manufacturing of Pharmaceutical Products"

Yesterday (06 February 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...

Nov 19, 20232 min read

USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model

USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple guidances related...

Apr 5, 20232 min read

USFDA Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products &API

Today (o5 April 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft...

Mar 23, 20221 min read

Guidance on Renewal & Discontinuation of Authorisation on change of Status -Swiss Medic

This guidance document describes the rules that apply to the renewal or discontinuation of authorisation, how these rules are to be...