TITLE

FDA, Research Organizations Seek to Bolster Drug Submissions

AUTHOR(S)
Wechsler, Jill
PUB. DATE
September 2013
SOURCE
Applied Clinical Trials;Sep2013, Vol. 22 Issue 9, p12
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article informs that the U.S. Food and Drug Administration (FDA) has increased fees paid by pharma and biotech firms for 2014 authorized by the Prescription Drug User Fee Act (PDUFA). It states that decline in anticipated New Drug Applications (NDAs) submitted to the FDA can result in decreased pharma investment in research and development (R&D), increased drug development process cost, and reduced high failure rate of clinical trials.
ACCESSION #
90463684

 

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