Iterum Therapeutics (ITRM)

[swanlinbar]

$ITRM>"Finally, if approval is anticipated, labeling discussions are held between FDA and the Sponsor in order to reach agreement on the contents and wording of the prescribing information (i.e., product label, package insert). This is a critical step because it determines the labeled use for the product and impacts how the product may be marketed.

During this time any PMC, PMR, and risk management programs are negotiated. Because of tight time constraints, the Sponsor is encouraged to engage in clear and efficient correspondence with FDA and not to submit large amounts of new data to support labeling claims during this time."

https://www.nuventra.com/resources/blog/submitting-your-fda-marketing-application/?fbclid=IwAR3mO0qvMyz57tH6gSakeQMifJ0tlprfb6-9qjwyKhZIo6ohTMI1LWh2r5w