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Drug Information Summaries
NCI's drug information summaries provide consumer-friendly information about certain drugs that are approved by the U.S. Food and Drug Administration (FDA) to treat cancer or conditions related to cancer.
NCI Drug Dictionary
A dictionary that contains technical definitions, alternate names, and links to related information for more than 1,200 agents that are being used in the treatment of patients with cancer or cancer-related conditions.
Understanding the Approval Process for New Cancer Treatments
A look at how the U.S. Food and Drug Administration relies on the results of clinical trials to ensure the safety and effectiveness of new cancer treatments before they go on the market.
Approved Oncology Drugs
Information related to approved oncology drugs, oncology drug approval processes, regulatory information and other oncology drug resources.
New Approaches to Cancer Drug Development and Clinical Trials: Questions and Answers
Phase 0 trials expose the patient to less toxicity, and can be performed in less time, with fewer patients, than traditional phase I trials. By conducting a phase 0 trial researchers can weed out the drugs that aren't producing the desired effects much more quickly and can avoid moving those drugs onto phase I, II, and III trials.
Access to Investigational Drugs: Questions and Answers
A fact sheet that defines investigational drugs (drugs under study but not yet FDA approved) and describes the special conditions under which patients and their doctors can apply to receive these treatments. National Cancer Institute Fact Sheet 7.46
FDA Home Page
Cancer Liaison Program
Answers questions from the public about drug approval processes, cancer clinical trials, and access to investigational therapies.
Center for Drug Evaluation and Research
Electronic Orange Book of Approved Drug Products
Guidance Documents for Industry
Contains an archive of documents describing FDA policies on specific topics.
Industry Collaborations
Provides information regarding the process for co-developing an investigational anti-cancer agent with the NCI.
Investigator's Handbook
Provides information to investigators on specific procedures related to the development of clinical trials of investigational agents sponsored by the NCI's Division of Cancer Treatment and Diagnosis.
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