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Can i request faster review for vascepa s application?



After reviewing the available information, it is not explicitly stated whether you can request a faster review for Vascepa's application. However, the general process for drug approval and review by the Food and Drug Administration (FDA) is outlined.

The FDA's standard review period for new drug applications is 10 months, but there is an option for a priority review, which reduces the review period to 6 months for drugs that treat serious conditions and address unmet medical needs [1]. Whether Vascepa, a prescription medication for reducing triglyceride levels, would qualify for a priority review is not specified in the available information.

It's important to note that the FDA has a process in place for expediting the development and review of drugs for serious conditions, including the use of breakthrough therapy, fast track, and priority review designations [2]. However, it is up to the FDA to determine if a drug meets the criteria for these designations.

In conclusion, while it may be possible to request a faster review for Vascepa's application, it is ultimately up to the FDA to determine if the drug meets the criteria for a priority review or other expedited review options.

Sources:

1. [FDA](https://www.fda.gov/patients/drug-development-process/step-4-fda-review-application)
2. [DrugPatentWatch.com](https://drugpatentwatch.com/fda-priority-review-process)



Follow-up:   Can I expedite Vascepa's application review process? How can I request a faster review for Vascepa? Is there a way to quicken Vascepa's approval decision?





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