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An Overview of Coders Breakthrough Therapy Designation Program CDR's Office of Communication Division of Drug Information December 1, 2015, Miranda Radio, BA, BSN, MA CDR Breakthrough Therapy Program
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What is cders?
CDERS stands for Company Data Exchange and Reporting System. It is an electronic system used for submitting regulatory information to health authorities.
Who is required to file cders?
Pharmaceutical companies and other healthcare organizations are required to file CDERS.
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CDERS can be filled out online through the designated portal provided by the health authorities.
What is the purpose of cders?
The purpose of CDERS is to ensure timely and accurate reporting of regulatory information to health authorities for monitoring safety and effectiveness of healthcare products.
What information must be reported on cders?
Information such as drug safety data, adverse events, clinical trial data, and product labeling updates must be reported on CDERS.
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