What information does the Postmarketing Study Commitments Web site include?
The site does not include requirements or commitments involving proprietary information (e.g., to evaluate chemistry or manufacturing and control issues). The information included on this site is based on FDA’s internal postmarket requirements and commitments database. FDA continuously verifies the information contained in the database to ensure its accuracy. The information on the Web site, including additions and status changes, is updated quarterly. (See question number 4.) To find out what information you can retrieve from this site, see question number 11.
