Building substantial evidence never ends

• In: Symposium D3: Benefit-risk planning through the product life cycle on Tuesday, 23 May 2017, 15:45-16:20
• At: Stockholm (Sweden) (2017)
• Type: Presentation
• By: PECK, Carl (University of California at San Francisco (UCSF), Bioengineering and Therapeutic Sciences, San Luis Obispo, United States)
• Co-author(s): Carl C. Peck: Bioengineering and Therapeutic Sciences, University of California at San Francisco (UCSF), San Luis Obispo, United States
  
• Abstract:

       Although “substantial evidence of effectiveness” is required by the US FDA for marketing approval of new therapeutic products, the Agency has long based its initial and subsequent approval decisions, more or less, on the “totality” of evolving evidence for effectiveness and safety.  For the initial approval, the decision calculus for

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