Since 2007, the U.S. Food and Drug Administration (FDA) has had the authority to require pharmaceutical manufacturers to conduct studies and clinical trials to determine the risks associated with one of their products. Also known as postmarketing requirements (PMRs) and commitments (PMCs), these studies aim to gather extra data about a product’s efficacy, optimal use, and safety.
The difference between PMRs and PMCs lies in whether they are legally compulsory. Postmarketing requirements encompass studies and trials that manufacturers must conduct in agreement with one or more regulations. Meanwhile, postmarketing commitments are trials and studies which are not required by any statute but the sponsor has agreed to do.

Types of post-approval studies that may be required
After approving a product for the market, the FDA still has the power to require manufacturers the following:
Deferred pediatric studies.
Trials and studies that demonstrate the clinical benefits of drugs that entered the market via the accelerated approval pathway.
Studies on products approved under the Animal Efficacy Rule to demonstrate safety and efficacy in humansÂ
The assessment of a known serious risk related to drug usage.
The investigation of an unexpected serious risk when available data indicates its potential existence.
An original drug may have more than one postmarketing requirement or commitment.
How are the PMRs and PMCs' data managed?
The Federal Food, Drug, and Cosmetic Act requires manufacturers to report the progress of their PMRs and PMCs annually. The information on postmarketing studies and clinical trials is available in a database published by the FDA, except for postmarketing commitments containing proprietary information such as the data related to manufacturing, control issues, and chemistry evaluations. A single annual report may address multiple requirements or commitments for a particular NDA or ANDA.Â
In addition to publishing the data, the FDA has the task of verifying the information of PMRs and PMCs to ensure accuracy. Once all PMRs and PMCs have been fulfilled, the manufacturer must no longer submit the annual progress report.Â
Postmarketing requirements and commitments are critical tools to evaluate that approved drugs are safe and effective. The FDA promotes the importance of continuous evaluation in the pharmaceutical industry by mandating or encouraging additional studies. This system not only protects public health but also ensures that approved drugs meet the highest efficacy and quality standards throughout their lifecycle.Â
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