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  1. 1. new drug application(NDA) •‘I want a new drug’--huey Lewis •ok huey….about $800 million and 10 years. •1 in 5 new drugs get through NDA •FDA wants…. •development stage----animal testing results, other countries, then approval for clinical trials •new drug application----must be approved by committees in medical, microbiology, pharmacology, chemistry, statistical •phase 1---a few healthy volunteers to get max tolerated dose
  2. 2. new drug application • phase II----hundreds of volunteers with target disease. if effective keep going to….. • phase III----several thousand volunteers, double blind, placebo or vs known competitor • NDA is turned into FDA for approval • if approved drug goes on sale. • phase IV---adverse drug problems are reported to FDA • IND review---investigational new drug. permit for interstate shipment of nonapproved drugs.
  3. 3. patent period/generic drugs • expires 20 years after application. • others can make the product after 20 years but must show equivalence and must use a new name.