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Wednesday, 20 January 2016
eCTD Issues for ANDA Submissions
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Post the implementation of GDUFA, in the current year 4 cohort of FY 2016, there has been a very significant positive change with respect ...
88 comments:
Sunday, 3 March 2013
GDUFA AND ITS CONSEQUENCES
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History and background of GDUFA: The one hundred twelfth congress of the United States of America at the second session o...
148 comments:
Tuesday, 2 October 2012
How to get a job in the field of Regulatory Affairs ?
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This article is aimed at listing down the simple steps/facts, which I hope will help in solving the big riddle of getting a job in ...
90 comments:
Friday, 23 March 2012
GRASE, Grandfathered and DESI Drugs
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GRASE Drugs - The abbreviation of the term GRASE is - Generally Recognized as Safe and Effective GRASE Drugs are certain old drugs that ...
39 comments:
Thursday, 8 March 2012
CEP
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What is the Full form of abbreviation, CEP? Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate...
13 comments:
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