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Participation in disclosing opinions on Clinical Considerations for Efficacy and Safety Assessment
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About Project
This guidance provides recommendations on the clinical data requirements for Human medicinal and biological products. It applies to data supporting new applications for drug, biologic, generic drug applications and type II variations regarding changes to therapeutic indications.
09/01/2023 - 09/03/2023
webmaster@sfda.gov.sa
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Last Modified Date: 19/01/2023 - 10:52 AM Saudi Arabia Time
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