Well organized applications in the proper format can be reviewed in as little as 2-3 weeks, Li says. To shorten review times, she suggests that sponsors:
- Submit applications in the standardized CTD format that was published on the FDA public website on 2010
- Submit in both Word and PDF formats
- Create PDF files of tables instead of scanning
- Submit SAS files only as .xpt files
- Make sure that data presented in the study report matches data in the SAS file
Li also suggests that sponsors should ensure that all applications include the following:
- A certificate of analysis (COA) for the reference listed drug product
- All protocols/SOPs for the in vitro test method
- All analytical SOP (procedural SOP and method validation SOP) for the in vitro test
- 20% chromatograms for drug in small particles/droplets by cascade impactor
- Complete (100%) raw numerical data for all of the in vitro and in vivo tests
For more information on the Orlando Inhalation Conference, click here.
This is the first of two articles based on Bing Li’s talk. To read her answers to frequently asked questions about nasal spray ANDAs, click here
