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Initial Shared System REMS approval: 04/2019
Most Recent Modification: 05/2021
Mifepristone Tablets, 200 mg
Progestin Antagonistic EVALUATION AND MITIGATION STRATEGY (REMS)
SINGLE SHARED SYSTEM FOR
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How to fill out update to fdas risk
How to fill out update to fdas risk
01
Log in to the FDA's MedWatch website
02
Navigate to the 'Submit an Adverse Event or Product Problem Report' page
03
Fill out the required fields with accurate information about the product, the adverse event, and any contributing factors
04
Include any supporting documentation or evidence related to the adverse event
05
Review the information entered for accuracy and completeness before submitting the update
Who needs update to fdas risk?
01
Manufacturers of FDA-regulated products
02
Healthcare providers
03
Consumers who have experienced adverse events
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What is update to fdas risk?
Update to FDAS risk is a process to provide the FDA with new information regarding the risks associated with a specific product or medical device.
Who is required to file update to fdas risk?
Manufacturers, distributors, and importers of medical devices are required to file update to FDAS risk.
How to fill out update to fdas risk?
The update to FDA’s risk form can be filled out electronically on the FDA's official website or submitted through the FDA's electronic submission gateway.
What is the purpose of update to fdas risk?
The purpose of update to FDAS risk is to ensure that the FDA has the most up-to-date information on potential risks associated with medical devices.
What information must be reported on update to fdas risk?
Information such as new studies, adverse events, recalls, and changes in manufacturing processes must be reported on update to FDAS risk.
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