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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...
Sharan Murugan
Feb 7, 20242 min read
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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...
Sharan Murugan
Nov 19, 20232 min read
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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...
Sharan Murugan
Apr 5, 20232 min read
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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...
Sharan Murugan
Mar 24, 20221 min read
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