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Drug Development and Approval

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Specific Drugs

  • Cancer Drug Information
    List of cancer drug information summaries from NCI. These summaries have information about cancer drugs and cancer drug combinations.
  • NCI Drug Dictionary
    A dictionary that contains technical definitions, alternate names, and links to related information for 2,300+ agents that are being used in the treatment of patients with cancer or cancer-related conditions.

Drug Development and Approval

  • 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.
  • Access to Investigational Drugs
    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.
  • Investigating Nature's Mysteries for Drug Development
    Living in the competitive environment of a coral reef, marine invertebrates, such as delicate sea squirts and immobile sponges, must find creative ways to protect themselves. For some organisms, having an arsenal of toxic chemicals is what keeps them alive. Scientists in NCI-Frederick's Natural Products Branch (NPB) are exploring ways to harness these chemicals, and those from other plant, animal, and microbial sources, for drug discovery.
  • Food and Drug Administration (FDA)
    This U.S. Federal agency is responsible for assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radiation.
  • 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
    As part of the U.S. Food and Drug Administration, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
  • Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
    The Orange Book lists drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act.
  • Industry Collaborations
    Provides information regarding the process for co-developing an investigational anti-cancer agent with the NCI.
  • Investigator's Handbook
    A manual for investigators participating in clinical trials of investigational agents sponsored by NCI's Division of Cancer Treatment and Diagnosis.