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FDA Modernization Act of 1997

Known as: FDAMA 
National Institutes of Health

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
2017
2017
A prominent feature of statistical reasoning for nearly a century, the p-value plays an especially vital role in the clinical… 
2010
2010
  • Jesse M Boodoo
  • American Journal of Law & Medicine
  • 2010
  • Corpus ID: 8532926
Drug compounding is the long-standing pharmacy practice of mixing, combining, or altering ingredients to create drugs tailored to… 
Review
2007
Review
2007
This paper elaborates two sets of statistical models for the analysis of regulatory review deadlines or “review time goals” and… 
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Review
2003
Review
2003
Professor O'Reilly's study of recent drug review legislation applies a historical and holistic view of promotion practices for… 
Review
2003
Review
2003
OVERVIEW OF DRUG DEVELOPMENT AND THE FDA, D.J. PisanoBrief History of Drug Laws and RegulationsRegulatory Oversight of… 
Review
2003
Review
2003
  • L. Breslow
  • Harvard journal on legislation
  • 2003
  • Corpus ID: 34486901
On January 4, 2002, President Bush signed into law the Best Pharmaceuticals for Children Act, which is the government's most… 
Review
2000
Review
2000
The Prescription Drug User Fee Act of 1992 (PDUFA) is credited with the dramatic reduction in new drug approval times seen since… 
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2000
2000
  • K. R. Karst
  • The American University law review
  • 2000
  • Corpus ID: 45946019
Introduction........................................................................................ 740 I. Pediatric Testing: A…