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  • The FDA published the proposed rule "Annual Summary Reporting Requirements Under the Right to Try Act," that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible ...

  • Title: THE POWER OF AI IN BIOLOGICS DRUG DESIGN, PRE-CLINICAL AND CLINICAL DEVELOPMENT Date: 21 July 2020, 10:00am - 11:30am EST (14:00 - 15:30 GMT) Registration Link:   https://diaglobal.zoom.us/webinar/register/WN_VUvDHq7fRzO_057PMaZRr4 Brought ...

  • I am writing to get your advice on assessing the causality specific to the adjuvant. Please let us know if investigators or Independent Data Monitoring Committee (IDMC) was requested to make causality assessment only for the adjuvant, when used in combination ...

  • Such great points.. I absolutely agree that while we are currently operating in the gray area regarding this that the best thing to do would be to send in the reports. It is always best to be conservative in that regard. With that being said, time to ...

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  • Thank you Karen for your response. It helped me. ------------------------------ Kapil Bhutada Associate Director Clinical QA Medicago Acton MA +1(617)834-7701 ------------------------------

  • Update posted on 16-April-2020 regarding the re-release of MedDRA Version 23.0 can be found here:  https://www.meddra.org/news-and-events/news/meddra-version-230-update-available-19-april The MSSO will hold two webinars at the dates and times below ...

  • Thank you for sharing ------------------------------ Denise Pappas Director Business Development Norwich Clinical Services, Pvt., Ltd Morristown, NJ 07960 denise.pappas@norwichclinical.com ------------------------------

  • https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug ------------------------------ Denise Pappas Director Business Development Norwich Clinical Services, Pvt., ...

  • Thank you very much, Dr. Vijay. We are very grateful for your work and the work of your co-authors.and we're grateful we can share it through our Global Forum to DIA's global network. Thank you very much indeed. ------------------------------ Chris ...

  • Dear Catherine, It was a wonderful conference for me, not only in the context of the variety of the contents presented but also in the wide range of networking it facilitated. Thank you so much for calling out my session separately. It meant a lot to ...

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