Fundamentals of regulatory writing: the document development process

Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across multiple functions. Document development is a multistep processwith the regulatory writer acting as project leader. This article describes each of the stages of theprocess and suggests best practices for achieving timely project completion and document delivery.

When Will There Be a COVID-19 Vaccine for Kids?

By Elaine K. Howley Over the last year, a heroic effort has brought about multiple safe and effective vaccines that offer excellent protection against COVID-19. States and the federal government have made considerable progress rolling out these vaccines (…)

How COVID-19 has fundamentally changed clinical research in global health

By: Jay J HParkMSc, RobinMoggPhD, Gerald ESmithMSc, EtheldredaNakimuli-MpunguPhD, FyezahJehanMBBS, Craig RRaynerPharmD, JeanineCondoPhD, Eric HDecloedtPhD, ProfJean BNachegaPhD, GilmarReisPhD, ProfEdward, JMillsFRCP COVID-19 has had negative repercussions on the entire global population. Despite there being a common goal that should have unified resources and efforts, there have been an overwhelmingly large number of clinical trials that have been … Continued

Economic and Clinical Burden of Virus-Associated Hemorrhagic Cystitis in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation in the United States

Authors: Joseph McGuirk, Clint Divine, Seung Hyun Moon, Aastha Chandak, Zhiji Zhang, Genovefa A. Papanicolaou Hemorrhagic cystitis (HC) caused by viral infections such as BK virus, cytomegalovirus, and/or adenovirus after allogeneic hematopoietic stem cell transplantation (allo-HCT) causes morbidity and mortality, affects quality of life, and poses a substantial burden to the health care system. At … Continued

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