Prescribing Information Approval and CommunicationUpon approval...

Prescribing Information Approval and Communication

Upon approval of the application:

FDA’s Center for Drug Evaluation and Research posts the approved Prescribing Information for prescription medicines and therapeutic proteins to Drugs@FDAFDA’s Center of Biologics Evaluation and Research posts approved Prescribing Information for vaccines, allergenic products, blood and blood products, plasma derivatives, and cellular and gene therapy products on CBER’s webpage.

Within 14 days of approval of the application (including the Prescribing Information), the drug company submits Structured Product Labeling to FDA’s electronic listing system. Subsequently electronic labeling is posted to several websites including FDA’s FDALabel and NIH’s DailyMed. See the 2017 presentation on the differences between labeling on Drugs@FDA versus DailyMed.

If all is well with the labelling, BOT will be up on these links.
If labelling all good why not just approve at the one meeting. Save coming back in a few weeks. Handshakes all round??