Duplication in Chinese sponsored Randomized clinical trials...

  • 11 Jan 21

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.

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FDA 2020 new drug approvals...

  • 10 Jan 21

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".

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Draft guidance from FDA "IND Submissions for Individualized Antisense Oligonucleotide Drug Products"

  • 05 Jan 21

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taking the first steps in bringing clarity to this emerging area of individualized drug development by releasing a new draft guidance.

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Happy New Year..

  • 31 Dec 20

Turkish Clinical Research Association wishes a happy and healthy 2021 without COVID-19...

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Coronavirus boom in scientific writing..

  • 17 Dec 20

According to an analysis in Nature, COVID-19 pandemic transformed research publishing in 2020.

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Elsevier: The challenges of publication and pre-print in clinical research...

  • 04 Nov 20

2 December, 3PM GMT / 11AM EST

Speaker:
John McConnell, Editor, The Lancet Infectious Diseases

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The top cities for research in the Nature Index 2020...

  • 29 Sep 20

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.

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FDA Updates Question-and-Answer Appendix in Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency

  • 24 Sep 20

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

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7th International Multidisciplinary Good Medical Research Digital Congress..

  • 10 Sep 20

The Congress will be held on 24 October 2020 by MedicRes.

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FDA Finalizes Enforcement Procedure for ClinicalTrials.gov Reporting Requirements...

  • 17 Aug 20

To ensure transparency FAD updated ClinicalTrials.gov reporting requirements, issuing final guidance last week that confirms penalties of up to $10,000 per violation.

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