The clinical development planUpadhyay, NamrataMedical Writing
In 2022, the General Office of the State Council of China issued the “14th Five-Year Plan” for the Development of TCM, which clearly named a number of integrated TCM and WM diagnosis and treatment programs that can reflect the "appropriate Chinese and Western medicine" [3]. Accelerating th...
Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: De...
This article introduces the updated version of the Iranian guideline for the diagnosis and treatment of hypertension in adults. The initial version of the national guideline was developed in 2011 and updated in 2014. Among the reasons necessitating the u
• National Key Research and Development Program during the 14th Five-Year Plan: Collaborative Organization for the Research of New Targets for Screening and Intervening Hypercholesterolemia of China 2022 • Organization with a To-be-built National Standardized Atrial Fibrillation Center under the Natio...
People with ADPKD should have a “sick-day plan” and be advised to skip doses of tolvaptan in situations in which they are at risk of volume depletion, such as those with limited access to water, those with increased fluid losses, and activities in warm weather. Individual adjustments shoul...
clinical sites provided data in the US and European natural history cohorts that served as the external controls in BHV4157-206-RWE. As per instructions from FDA on the real-world evidence study design and statistical analysis plan,...
during the drug clinical trial period, the clinicaltrial applicant fails to promptly adjust the clinical trial plan, suspend or terminateclinical trial, or fails to report to the drug administrative department of theState Council, upon discovery of safety issues or other risks; fail to establish an...
The world’s plan to make humanity sustainable is failing. Science can do more to save it There is no planet B, and the UN’s Sustainable Development Goals are heading for the rocks. Researchers around the world must do their bit to change that. Editorial20 Jun 2023 Nature The human ...
. fda pilots pre-certification program to regulate software as a medical device the fda has recognized the need for a new regulatory paradigm to evaluate rapidly advancing technology and provide clearance for clinical use. as part of its digital health innovation plan, the agency is...