Zynerba Pharmaceuticals (ZYNE)

[dhbuzz]

How long does it typically take for the FDA to review a NDA?

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Remember Zygel has been fast tracked by FDA for FX Syndrome ,that could mean that 12 month period is cut to 6 month.

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A standard review means that the FDA can take as long as 12 months after the NDA is submitted to review the data and grant approval. With a priority review, the FDA calls on a larger number of staff to review the NDA, reducing the approval time to less than six months.