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CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:761108Orig1s000
Remarks Evaluation and Mitigation Strategy (REMS) Document
ULTOMIRIS (ravulizumabcwvz) REMS Program
I. Administrative InformationApplication
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761108orig1s000 - accessdatafdagov is needed by individuals or organizations who are required to provide specific information or data to the Food and Drug Administration (FDA) as part of a regulatory process.
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What is 761108orig1s000 - accessdatafdagov?
761108orig1s000 - accessdatafdagov is a form used by the FDA for regulatory submissions related to drugs or medical devices.
Who is required to file 761108orig1s000 - accessdatafdagov?
Manufacturers, distributors, or applicants of drugs or medical devices are required to file 761108orig1s000 - accessdatafdagov.
How to fill out 761108orig1s000 - accessdatafdagov?
761108orig1s000 - accessdatafdagov can be filled out electronically on the FDA's online submission platform.
What is the purpose of 761108orig1s000 - accessdatafdagov?
The purpose of 761108orig1s000 - accessdatafdagov is to provide the FDA with important information about drugs or medical devices for regulatory review.
What information must be reported on 761108orig1s000 - accessdatafdagov?
Information such as product details, manufacturing process, clinical trial data, and labeling must be reported on 761108orig1s000 - accessdatafdagov.
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