RE: So its Manyana...9 Sep 2020 22:18
This is from the FDA website. The input relates to if they need special advice.
If such input is needed, FDA’s response may be delayed. If such a delay occurs, FDA should inform the sponsor as soon as practicable, but no later than 45 calendar days of receipt of the Request, generally by fax or email followed by a mailed letter. The communication will include the reason for the delay, the anticipated date of FDA’s response, and an overview of the specific issues that will be reviewed.