Postmarketing study commitments
As part of the regulatory approval process in the United States, commitments to conduct further studies once approval has been granted can be requested of or agreed to by a sponsor.
In some situations, commitments may be agreed once the product is on the market. These studies build on the data package submitted for approval and can provide additional information about safety, efficacy or use of the product in specific populations (such as infants or children).
View a summary (PDF) of the clinical and preclinical commitments that are currently active for AstraZeneca products. The summary contains:
- A brief description of the commitment
- The date the commitment was issued
- The FDA projected completion date of the commitment
- The current status of the commitment along with any necessary explanatory notes
Readers may notice some differences between the status of a commitment reported here when compared to that on the FDA website. Typically this is can be explained by the fact that FDA requires time to review the data/study and also to update its website. In addition, some studies that are summarized here are not “formal” commitments that are captured on the FDA website, but were initiated following a dialogue with FDA and are listed here for completeness.
This website does not contain chemistry, manufacturing and control (CMC) commitments, nor commitments for which AstraZeneca LP, AstraZeneca UK Ltd or iPR Pharmaceuticals Inc are not the FDA licence holder. This website will be updated twice a year and once a commitment is deemed to be completed (or FDA release the company from the commitment), it will be removed from the site.