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CTP has stressed that the PMTA submission is an opportunity to tell the FDA a story about why a product should get market authorization. If the current May 12, 2020 deadline for submission remains in place, CTP indicated its intent to expedite the review of all applications and complete them within one-year. In order to accomplish this goal, CTP emphasized to the industry the importance of filing a complete application. Read a summary of the meeting in FDLI Update magazine.

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