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Participation in disclosing opinions on Clinical Considerations for Efficacy and Safety Assessment

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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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Participation in disclosing opinions on Clinical Considerations for Efficacy and Safety Assessment
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Health Sector - Saudi Food and Drug Authority
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Last Modified Date: 19/01/2023 - 10:52 AM Saudi Arabia Time

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