Streamlining Postapproval Submissions Using ICH Q12 & SCDM
ISPE
AUGUST 29, 2022
In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. In July 2021, Health Canada (HC) released an updated draft guidance for its Post-Notice of Compliance (NOC) Changes and solicited public comments. Published 23 March 2021.
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