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New Drug Approval

Known as: Approval, New Drug, Drug Approval, New, approvals drugs new 
National Institutes of Health

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Drug Approval

Papers overview

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Review
2017
Review
2017
Value in Health Volume 20 , Issues 3 & 4 VIH INFORMATION The following
The authors review new drug approvals (NDAs) by the Food and Drug Administration for 2006-2010 to show that 24.1% of new drugs… 
Review
2016
Review
2016
FDA analysis of the characteristics and relevance of serious adverse events that are Grade 1 or 2 in severity.
2538Background: In New Drug Approval (NDA) applications, sponsors must provide an integrated summary of the safety of the drug… 
Review
2015
Review
2015
The year's new drugs & biologics, 2014: Part I.
A year-end wrap-up of new drug approvals and launches reveals that activity in the pharmaceutical industry continues at a high… 
Review
2014
Review
2014
A new ICH M7 compliant expert alert system to predict the mutagenic potential of impurities Abstract
  • 2014
  • Corpus ID: 28214415
The current International Conference on Harmonisation (ICH) M7 guideline on drug impurities states that two distinct in silico… 
2014
2014
AT-41MULTI-CENTER CLINICAL TRIAL OF INTRAVENOUS ADMINISTRATION OF BEVACIZUMAB FOR THE TREATMENT OF RADIATION NECROSIS IN THE BRAIN TO OBTAIN NDA APPLICATION FOR ON LABEL USE IN JAPAN.
Recent radiotherapeutic modalities including particle radiotherapy, IMRT, and SRS are able to irradiate tumor tissue with high… 
2005
2005
Europe caught in innovation quagmire
As new drug approval rates drop in Europe compared to the US, the EU Commission plans to spur innovation by doubling financial… 
Review
1998
Review
1998
The Joint Institutional Review Board in Taiwan
To provide an efficient and high quality institutional review board (IRB) review for multicenter trials, a joint IRB (JIRB) was… 
1989
1989
Drug development for cancer: implications for chemical modifiers.
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