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 five-year study, conducted in partnership with the Thrombolysis in Myocardial Infarction (TIMI) Study Group, will address the post-marketing requirement from the U.
AUSTRI was undertaken as a post-marketing requirement of GSK for the US Food and Drug Administration (FDA).
Nine manufacturers of these medications formed a consortium known as the Opioid Post-marketing Requirement Consortium (OPC) to carry out research aimed at understanding safe and appropriate use for chronic pain.
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.
Completion of COMBI-d is a post-marketing requirement for the FDA's accelerated approval for the combination in the US.
and the MAA for NB32 by the European Medicines Agency (EMA); the ability to reach agreement with the FDA on a post-marketing requirement for cardiovascular outcomes; the timing of Orexigen's response to the Day 180 List of Outstanding Issues; the timing and potential for a Takeda launch of NB32; the benefit risk profile for NB32; the use by Takeda of 900 sales representatives focusing on primary care physicians in the U.
ApoPharma has agreed to several post-marketing requirement and commitments.
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.
Reaching this milestone satisfies European post-marketing requirements.
said that the goals of these services are both to optimize medical clients' pathway to marketability and to ensure their high-quality adherence to all post-marketing requirements.
Further, brentuximab vedotin may be approved pursuant to the accelerated approval regulations and we may be subject to completing post-marketing requirements and obtaining preapproval of our marketing and promotional materials.
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