FDA Decision is Expected Within 90 Days of Initial Submission; However, the Process May be Paused if Additional Information is Requested AUSTIN, TX / ACCESSWIRE / August 8, 2024 / Monogram ...
On October 6, 2024, Monogram (NASDAQ:MGRM) announced it had received an Additional Information Request (“AIR”) from the U.S. Food and Drug Administration (“FDA”) on September 30, 2024, regarding its ...
Application was Submitted on July 19, 2024, Passed the FDA Administrative Review, and is Now Under Substantive Review FDA Decision is Expected Within 90 Days of Initial Submission; However, the ...