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According to an analysis in JAMA, out of 470 Chinese sponsored Randomized clinical trials, 12% of them are published at least twice in other medical journals. This is more prominent if the original study is published in Chinese.
FDA/CDER, approved 53 new drugs in 2020. 58% of the approvals are orphan drugs, 40% first-in-class, and 75% are approved first in USA. CDER approves approximately 40 new drugs each year. 68% of the drugs are approved thorough "Expedited Programs for Serious Conditions".
In the last few years, advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. Development needs to proceed very quickly to have a chance at helping the individual. FDA is taking the first steps in bringing clarity to this emerging area of individualized drug development by releasing a new draft guidance.
Turkish Clinical Research Association wishes a happy and healthy 2021 without COVID-19...
According to an analysis in Nature, COVID-19 pandemic transformed research publishing in 2020.
2 December, 3PM GMT / 11AM EST
John McConnell, Editor, The Lancet Infectious Diseases
Nature Index is published based on the contribution of cities to science. This year Being is in the first position followed by New York, Boston, San Francisco-San Jose and Shanghai.
The updated guidance includes a new question-and-answer regarding a clinical trial investigator’s responsibility to review all investigational new drug application safety reports