Postmarketing commitments (PMCs) and requirements (PMRs) refer to studies and clinical trials that sponsors conduct after approval to gather additional information about a product's safety, efficacy, or optimal use. Some of the studies and clinical trials may be required by FDA; others may be studies or clinical trials a sponsor has committed to conduct.
Additional information about these studies can be found on the FDA website.
Endo is committed to patient safety and to supporting transparency about PMC and PMR obligations. Below is a list of Endo’s ongoing and completed PMCs and PMRs. Additional information about these studies can be found on the FDA website. Click Here and search “Endo” in the “Applicant" field to learn more about our requirements/commitments.