FDA approvals and clearances › About this data
FDA approvals and clearances
The FDA publishes its decisions on drugs and medical devices through openFDA. We list approved drug applications and the changes approved to them, 510(k) clearances of devices and premarket approvals (PMA) of higher-risk devices, and match the applicant to a public company when the name lines up. The page opens on new brand-name drugs and biologics: the first approval of a new drug application (NDA) or biologics license application (BLA).
- Where it comes from
openFDA, the FDA's public data service, publishes the FDA's own records. openFDA asks users not to imply that the FDA endorses their product or service: this site is not endorsed by or affiliated with the FDA, and the FDA makes no warranty about the data.
Who reports it: The FDA decides; openFDA publishes the FDA's records. The applicant is the company named in the FDA's record for the application.
Official sources
- How often we update it
- Every day
- Last updated
- (13 hours ago)
- Coverage
- Decisions dated since 2015. The FDA refreshes its files on its own schedule, so a decision can appear days to weeks late. Decisions still to come are not shown.
- Worth knowing
- This is a record of decisions already made. It is not a calendar of coming decisions: a drug under review does not appear, and we show no review dates. openFDA asks users not to imply that the FDA endorses their product or service: this page is not endorsed by or affiliated with the FDA, and the FDA makes no warranty about the data. It is not for medical decisions. Most applicants, such as generic makers and private device makers, do not match a public company, and a subsidiary or a differently spelled name can be missed, so a row with no ticker may still belong to one. A clearance is not an approval, and many approved supplements are minor.
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