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Home » Investigator Beware: When Research With Marketed Drugs Calls For INDs
Investigator Beware: When Research With Marketed Drugs Calls For INDs
March 14, 2012
Studies of approved drugs that involve a route of administration or dosage level that significantly increases the risks or lowers the acceptability of risks associated with the drug are not exempt from clinical trial regulations and must be conducted under an investigational new drug (IND) application, an FDA warning letter reminds researchers.