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PROMETRIKA is very excited to present the inaugural issue of our biannual newsletter. Now in its 15th year, PROMETRIKA has much to celebrate and much to look forward to as we collaborate with our client companies to bring new treatments to patients and the clinicians who treat them worldwide.
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PROMETRIKA to Present Three Sessions at the 2018 American Medical Writers Association Conference in Washington, DC
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PROMETRIKA, LLC is excited to be in attendance at the DIA 2018 Global Annual Meeting in Boston, MA on June 24-28, 2018. Please visit Booth #1132 to learn more about the clinical research services we offer and meet our team members.
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A Message from Our Founder
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A single review of the past year within the biopharmaceutical industry cannot comprehensively cover all developments. In 2017, FDA issued 226 draft and final guidance documents addressing its current thinking with regard to food, laboratory, blood banking, drug, and device regulations. With respect to the research of drugs and biologics, some of these guidances covered topics in drug and biologic technology, product classification (drug, device, or combination), pediatric rare and serious diseases, and software as a medical device (SaMD). In the following segments, a few of these topics are addressed, particularly as they pertain to areas of heightened activity in the industry. Under new FDA leadership, the industry looks forward to further support of innovation in clinical research.