FDA says Sinopharm EUA application lacks documents

The Food and Drug Administration (FDA) will wait for Sinopharm to submit its required documents before evaluating and granting the emergency use authorization (EUA).

In a public briefing, FDA Director General Eric Domingo confirmed that a local pharmaceutical company distributor has applied for an EUA on Monday. However, it is still lacking the needed documents for an evaluation. The company only submitted the Phase 1 trial and letter of intent.

FDA Dir. Gen. Domingo assured that the process for the evaluation will be fast provided that all necessary documents are given to them. The process will be quicker if an EUA from a stringent regulatory authority has been given to the company. – Report from Mark Fetalco

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