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CDER Data Standards Manual Vocabulary Change Request Form - fda

CDER Data Standards Manual Vocabulary Change Request Form - fda 2025

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The document is a Vocabulary Change Request Form intended for FDA employees to propose changes to the CDER Data Standards Manual. It includes fields for personal information, type of action requested (add, change, or delete a term), justification for the action, and an assessment of its advantages and disadvantages.

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Click ‘Get Form’ to open it in the editor.
Begin by filling in your Name, Title, and Office as an FDA Employee. Ensure all required fields marked with an asterisk (*) are completed.
Enter your Work Phone Number and Email Address for contact purposes.
Provide the CDER DSM Monograph Number relevant to your request.
Specify the Date Action Required By to indicate urgency.
Select the Type of Action Requested: Add a Term, Change a Definition, or Delete a Term.
In the Summary of Justification for the Action section, clearly articulate your reasoning. You can also attach any supporting files as needed.
Outline the Advantages and Disadvantages of the proposed action to provide a balanced view.

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The Food and Drug Administration (FDA) Philippines established the Certificate of Product Notification (CPN) as a requisite for companies to provide consumers with a better awareness of certain products, specifically those under the Medical Device Notification, Cosmetic Product Notification, Toys and Childcare Articles

What is the FDA 513 G request for information?

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What is the FDA data Standards Manual?

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What is the FDA CDER?

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What is the FDA information disclosure?

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CDER Data Standards Manual Vocabulary Change Request Form - fda 2025

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