Post Marketing Commitments
Post Marketing Commitments (PMCs) and Post Marketing Requirements (PMRs) are studies
and clinical trials conducted by a sponsor after the Food and Drug Administration
(FDA) has approved a drug or biological product. The studies/trials are designed
to generate additional information about the product’s safety, efficacy, or optimal
use. PMCs are studies or trials a sponsor has agreed with FDA to conduct; they are
not required by statute or regulation. PMRs are studies or trials that sponsors
are required to conduct post-approval according to statute or regulation.
Forest Laboratories, Inc. is subject to PMCs and PMRs covering a range of studies/trials
in various stages of development. Descriptions and information about the nature
and status of the PMRs and PMCs currently active for Forest products can be found
clicking here. In addition, the FDA website provides a searchable database
of information on PMRs and PMCs, which can be accessed by clicking here: FDA website.
Additional background information on PMCs and PMRs, including a summary of relevant
legislative and regulatory provisions and answers to frequently asked questions,
also is available through the FDA website at: Introduction page on FDA website.