மருத்துவ சோதனைகள் ஒழுங்குமுறை News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Stay updated with breaking news from மருத்துவ சோதனைகள் ஒழுங்குமுறை. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.

Top News In மருத்துவ சோதனைகள் ஒழுங்குமுறை Today - Breaking & Trending Today

Six-month countdown to go-live for the Clinical...

Six-month countdown to go-live for the Clinical...
newsincyprus.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from newsincyprus.com Daily Mail and Mail on Sunday newspapers.

European Commission , Clinical Trials Regulation , Clinical Trials Information System , ஐரோப்பிய தரகு , மருத்துவ சோதனைகள் ஒழுங்குமுறை , மருத்துவ சோதனைகள் தகவல் அமைப்பு ,

What To Watch As EU Clinical Trial Compliance Changes - Food, Drugs, Healthcare, Life Sciences


To print this article, all you need is to be registered or login on Mondaq.com.
Earlier this year, industry became more intimately familiar with
the clinical trials reporting requirements in the U.S. when, on
April 27, the 
U.S. Food and Drug Administration sent a notice of
noncompliance to Acceleron
Pharma Inc. identifying the company s failure to submit
study results from a November 2017 trial that tested the efficacy
of dalantercept and axitinib, proposed treatments for renal cell
carcinoma.
As sponsors and principal investigators seek to learn from the
Acceleron example, it is important for industry to consider
reporting requirements not just in the U.S., but also for ....

Martinh Voss , Us Public Health Service , Drug Administration Modernization , Us Department Of Health , Human Services , National Institutes Of Health , European Free Trade Association , Drug Administration , Drug Administration Press , National Library Of Medicine Press , National Library , Public Health , European Union , European Medicines Agency , Acceleron Pharma Inc , Drug Administration Amendments , Acceleron Pharma , Clinical Trials Regulation , Trials Information , National Institutes , Drug Administration Amendments Act , Economic Area , Clinical Trials Directive , Health Service Act , Clinical Trials , Information System ,

What To Watch As EU Clinical Trial Compliance Changes


ADVERTISEMENT
What To Watch As EU Clinical Trial Compliance Changes
Law360 (July 13, 2021, 6:47 PM EDT) Earlier this year, industry became more intimately familiar with the clinical trials reporting requirements in the U.S. when, on April 27, the U.S. Food and Drug Administration sent a notice of noncompliance to Acceleron Pharma Inc. identifying the company s failure to submit study results from a November 2017 trial that tested the efficacy of dalantercept and axitinib, proposed treatments for renal cell carcinoma.
As sponsors and principal investigators seek to learn from the Acceleron example, it is important for industry to consider reporting requirements not just in the U.S., but also for the European Union given the Clinical Trials Regulation, which,. ....

European Union , Drug Administration , Acceleron Pharma Inc , Acceleron Pharma , Clinical Trials Regulation , ஐரோப்பிய தொழிற்சங்கம் , மருத்துவ சோதனைகள் ஒழுங்குமுறை ,