post-marketing requirement

post-marketing requirement

One or more postmarketing studies or clinical trials that the FDA requires of a new drug applicant.
References in periodicals archive ?
The trial is a post-marketing requirement (PMR) that was requested by the US Food and Drug Administration (FDA) to evaluate MACE for up to three years with aclidinium bromide.
ASCENT is a post-marketing requirement (PMR) trial requested by the US Food and Drug Administration (FDA) to evaluate MACE for up to three years with aclidinium bromide.
This Phase IIIb/IV clinical study, comprised of 12,000 patients, is being conducted over a 5-year period in partnership with the Thrombolysis in Myocardial Infarction (TIMI) Study Group and is intended to address the post-marketing requirement from the U.
This was undertaken by GSK as a post-marketing requirement of the US Food and Drug Administration (FDA).
ApoPharma, part of the Apotex group, has agreed to several post-marketing requirement and commitments, including further study of Ferriprox in patients with sickle cell disease who have transfusional iron overload.
AUSTRI was undertaken as a post-marketing requirement of GSK for the US Food and Drug Administration (FDA).
Completion of this study is a post-marketing requirement for the FDA s Accelerated Approval for the combination in the USA.
The FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure.
Sanofi said in a statement that this suspension was linked to a failure to comply with post-marketing requirements but that it was "not linked to the product profile.
MANILA, Philippines The manufacturer of Dengvaxia clarified that the suspension of the sale of its controversial vaccine was due to an alleged failure to comply with post-marketing requirements.
Critical issues include naming and labeling requirements, post-marketing requirements, and the use of the innovator drug maker's clinical data by potential follow-on manufacturers.
The FDA accepted the filing and the company worked with the agency to design and initiate a trial that could serve to fulfil post-marketing requirements under a Subpart H accelerated approval.
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