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Xeljanz XR Pfizer Inc. Dear Mr. Perry Your submission dated April 24 2015 for Xeljanz XR tablet is currently under review. Submit the requested information to items listed under number 2 above via email to Sadaf.Nabavian fda.hhs. 6. 1 ments/ElectronicSubmissions/UCM163560. pdf FDA eCTD web page onicSubmissions/ucm153574. htm For general help with eCTD submissions ESUB fda.hhs. Submit revised labeling incorporating the changes shown in the attached marked up labels via email to Sadaf.Nabavian...

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What is center for drug evaluation?

The Center for Drug Evaluation and Research (CDER) is a division of the U.S. Food and Drug Administration (FDA) that is responsible for ensuring the safety and effectiveness of prescription and over-the-counter drugs.

Who is required to file center for drug evaluation?

Manufacturers of pharmaceutical drugs are required to file a center for drug evaluation with the FDA.

How to fill out center for drug evaluation?

The center for drug evaluation can be filled out electronically through the FDA's Electronic Submission Gateway (ESG) system.

What is the purpose of center for drug evaluation?

The purpose of the center for drug evaluation is to provide the FDA with detailed information about the safety, efficacy, and quality of a pharmaceutical drug.

What information must be reported on center for drug evaluation?

The center for drug evaluation must include detailed information about the drug's active ingredients, manufacturing process, clinical trials, and potential side effects.

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