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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Eric Gervais, Executive Vice President Duchess, Inc. 919 Conestoga

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What is diclegis warning letter?

Diclegis warning letter is a letter issued by the FDA to inform healthcare professionals and patients about safety concerns or potential risks associated with the medication Diclegis.

Who is required to file diclegis warning letter?

The manufacturer of Diclegis is required to file the warning letter with the FDA.

How to fill out diclegis warning letter?

The manufacturer must include all relevant safety information, risk factors, and instructions for healthcare professionals and patients in the warning letter.

What is the purpose of diclegis warning letter?

The purpose of the diclegis warning letter is to ensure that healthcare professionals and patients are aware of potential risks associated with the medication and take appropriate precautions.

What information must be reported on diclegis warning letter?

The diclegis warning letter must include detailed information on known safety concerns, potential side effects, recommended dosage, contraindications, and any other relevant information.

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