FDA approval if I understand correctly, inspections were carried out by the FDA in the last Q!?
I have a listing here
Simplified representation of the testing process for drugs
1. animal testing
2. investigational new drug application (IND) with proposals for testing in humans
3. phase 1 studies in humans (usually with a group of 20 to 80 test subjects)
4. phase 2 human trials (usually with a group of up to 300 subjects)
5. phase 3 studies in humans (usually with a number of several hundred up to 3,000 test subjects)
6. time period before submission of a New Drug Application (NDA); time for meetings between FDA representatives and manufacturers of a new drug product
7. submission of the NDA - official step and question to the FDA to approve the drug for the U.S. market
8. FDA has 60 days to decide whether to accept the NDA (file) so that the application can then be reviewed (review).
9. if the FDA accepts the application, it assigns a staff team to review the manufacturer's research on the safety and efficacy of the drug.
10. the FDA reviews the labeling and package insert information submitted to it.
11. FDA conducts inspections of the manufacturer's facilities.
12. FDA staff approves the NDA (approval letter) or rejects it with a "complete response letter."
The source is on a German website:
https://www.gtai.de/de/trade/usa/zoll/standardpruefung-des-antrags-dauert-etwa-zehn-monate-582246