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Read more about the article Expedited programs for regenerative medicine therapies for serious conditions

Expedited programs for regenerative medicine therapies for serious conditions

  • Post published:August 19, 2021

Today, from Revio, we would like to share with you a review on a piece of guidance from the Food and Drug Administration (FDA): Expedited Programs for Regenerative Medicine Therapies…

Continue ReadingExpedited programs for regenerative medicine therapies for serious conditions
Read more about the article Draft Guideline: ICH S12. Non clinical biodistribution considerations for gene therapy products

Draft Guideline: ICH S12. Non clinical biodistribution considerations for gene therapy products

  • Post published:August 5, 2021

Today, from Revio, we would like to share with you a summary of the International Council for Harmonisation (ICH) guideline about nonclinical biodistribution considerations for gene therapy products. This draft…

Continue ReadingDraft Guideline: ICH S12. Non clinical biodistribution considerations for gene therapy products

Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)

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