Abstract
6001 Background: Title 21 part 312.34 of the Code of Federal Regulations provides for use of unapproved drugs to treat patients with serious or immediately life-threatening diseases ineligible for clinical trials and without available alternative therapy. EAPs can provide drugs to individual patients under “single patient Investigational New Drug (IND)” and to larger numbers under “treatment IND”. EAPs are implemented while sponsors are actively pursuing marketing approval. Reasonable evidence of clinical usefulness for the indication and sufficient safety information from ongoing or completed trials are required. EAPs are voluntarily initiated by the drug sponsor. FDA and IRB approvals and safety monitoring are required. Methods: Review of data reported from EAPs for the following drugs (indications): imatinib (chronic myelogenous leukemia), trastuzumab (breast cancer), temozolomide (malignant gliomas), oxaliplatin (colorectal cancer), gemcitabine (pancreatic cancer), gefitinib (non-small cell lung cance...
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