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. 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. 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.
