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FDA Approval

A written regulatory communication from FDA to an applicant, who submitted request to the agency to approve marketing or to license medical product… Expand
National Institutes of Health

Papers overview

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2018
2018
  • 2018
  • Corpus ID: 166219932
Since its establishment in 1906, the U.S. Food and Drug Administration (FDA) has approved over 1,500 novel drugs, with total… Expand
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Review
2018
Review
2018
Problem Definition: To approve a novel drug therapy, the U.S. Food and Drug Administration (FDA) requires clinical trial evidence… Expand
  • figure 1
  • figure 2
  • table 1
  • figure 3
  • table 2
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2017
2017
> The road is long > > With many a winding turn > > That leads us to who knows where > > Who knows where > > —“He Ain’t… Expand
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Highly Cited
2017
Highly Cited
2017
Approval of the drugtisagenlecleucel(Kymriah;Novartis) by the US Food and Drug Administration (FDA) for the treatment of… Expand
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2015
2015
Half a century ago the reporter for the Second Restatement of Torts, William Prosser, drafted Comment k to § 402A, defining the… Expand
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Highly Cited
2012
Highly Cited
2012
The FDA has approved a new radiopharmaceutical agent to assist in detecting causes of cognitive impairment other than Alzheimer's… Expand
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2004
2004
  • Krankenpflege Journal
  • 2004
  • Corpus ID: 40253900
 
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1994
1994
  • D W Sigelman
  • The International journal of risk & safety in…
  • 1994
  • Corpus ID: 44462895
Pharmaceutical manufacturers decry the purported burdens imposed by Federal regulation when it suits their proprietary interests… Expand
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