Thursday, September 10, 2020 2:06:09 PM
I suggest you grab a beverage this evening and read through ALL of my posts.
However, the excitement may keep you up all night.
But if you’re not up for that here’s a July post.
Waverunners Tuesday, 07/21/20 10:18:13 AM
Re: Waverunners post# 4991 0
Post # of 5249
Read below from FDA. No need for confusion.
Also in this May 2020 FDA published Update there is no mention of a backlog of applications to to a Covid related hold - so no delays in approval are expected and the 180 review process stands.
“ The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. The date of filing is the date that a PMA accepted for filing was received by the agency. The 180-day period for review of a PMA starts on the date of filing.“
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