What is the definition of PMR?

The term postmarketing requirement or PMR is used to describe all required postmarketing studies or clinical trials, including those required under FDAAA and those required under subpart H of 21 CFR part 314, subpart E of 21 CFR part 601, the Pediatric Research Equity Act, and the Animal Efficacy Rule.

Under section 505(o)(3) of the Act, FDA will require applicants to conduct a postmarketing study or studies or clinical trial(s) when the following conditions are met:

1. When the decision to require a postmarketing study or clinical trial is based on scientific data deemed appropriate by FDA, including information regarding chemically-related or pharmacologically-related drugs; and

2. When FDA has found —

a. before requiring a postmarketing study, that adverse event reporting under section 505(k)(1) of the Act and the new pharmacovigilance system that will be established under section 505(k)(3) will not be sufficient to meet the purposes described in condition 3 below; and 

b. before requiring a postmarketing clinical trial, that a postmarketing study will not be sufficient to meet the purposes in condition 3 below; and

3. When the purposes of the study or clinical trial, as described in section 505(o)(3)(B), are one or more of the following:

• To assess a known serious risk related to the use of the drug

• To assess signals of serious risk related to the use of the drug

• To identify an unexpected serious risk when available data indicates the potential for a serious risk

When these conditions are met, the Agency intends to require the study or clinical trial as a postmarketing requirement (PMR).