Article 49DYF Dengvaxia: Philippines FDA revokes CPR, ‘Sanofi has shown complete disregard of FDA rules’

Dengvaxia: Philippines FDA revokes CPR, ‘Sanofi has shown complete disregard of FDA rules’

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from Outbreak News Today on (#49DYF)

In a follow-up on the Dengvaxia situation in the Philippines, the Food and Drug Administration (FDA) reports permanently revoking the Certificates of Product Registration (CPR) of dengue vaccine Dengvaxia for the continued failure of manufacturer Sanofi Pasteur, Inc. to submit post-approval commitment documents. FDA Director General Nela Charade G. Puno pointed out that Sanofi has shown ["]

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