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U.S. DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA Electronic Case Filing System (ECF) ATTORNEY USER MANUAL FOR CIVIL CASES TABLE OF CONTENTS Getting Started............................................................................................................................12
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What is ecf paed?
ECF PAED stands for Electronic Case Filing for the Paediatric Exclusivity Program.
Who is required to file ecf paed?
Any pharmaceutical company seeking pediatric exclusivity for a drug product is required to file ECF PAED.
How to fill out ecf paed?
ECF PAED can be filled out electronically through the FDA's electronic submission portal.
What is the purpose of ecf paed?
The purpose of ECF PAED is to provide necessary information to the FDA for the evaluation of pediatric exclusivity for drug products.
What information must be reported on ecf paed?
ECF PAED requires information on the pediatric studies conducted for the drug product, including study design, results, and analysis.
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