post-marketing requirement

post-marketing requirement

One or more postmarketing studies or clinical trials that the FDA requires of a new drug applicant.
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This approval comes with a post-marketing requirement from the FDA to assess the cardiovascular safety of EVENITY in postmenopausal osteoporosis women.
Pfizer on February 19 said it has taken steps to transition rheumatoid arthritis study patients who were on tofacitinib 10 mg twice daily to tofacitinib 5 mg twice daily in the FDA post-marketing requirement study A3921133.
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.S.
Pfizer announced the company has taken steps to transition rheumatoid arthritis study patients who were on tofacitinib 10 mg twice daily to tofacitinib 5 mg twice daily in the Food and Drug Administration post-marketing requirement study A3921133.
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.
The study was a post-marketing requirement by the U.S.
This was undertaken by GSK as a post-marketing requirement of the US Food and Drug Administration (FDA).
AUSTRI was undertaken as a post-marketing requirement of GSK for 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.
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.
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