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MATERIAL REVIEWED Draft TIVICAY dolutegravir Tablets Patient Package Insert PPI received on and received by DMPP on May 28 2013. 8. 1 26. Send Labeling/PMR/PMC to Applicant 4. 8. 1 27. Labeling/PMR/PMC Discussions with Applicant Begin 4. NDA/BLA Product Name PMR/PMC Description 204790 Tivicay dolutegravir Conduct a trial to evaluate pediatric pharmacokinetics safety and antiviral activity of dolutegravir in HIV-1 infected integrase strand transfer inhibitor-na ve pediatric subjects 4 weeks to...
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Start by entering the relevant project details such as project name, project ID, and project description.
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What is pmrpmc development template?
The pmrpmc development template is a standardized form used for reporting development activities.
Who is required to file pmrpmc development template?
Any organization or individual involved in development activities is required to file the pmrpmc development template.
How to fill out pmrpmc development template?
The pmrpmc development template can be filled out online or manually, following the guidelines provided.
What is the purpose of pmrpmc development template?
The purpose of the pmrpmc development template is to provide a structured way to report development activities.
What information must be reported on pmrpmc development template?
Information such as project details, timelines, budgets, and stakeholders must be reported on the pmrpmc development template.
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