What is the primary purpose of the Treatment and Use of Investigational New Drug Act?

The primary purpose of the Treatment and Use of Investigational New Drug Act is to allow the administration of investigational drugs to patients who are not enrolled in clinical trials. This legislation serves to provide access to potentially life-saving therapies for patients with serious or life-threatening conditions when no other satisfactory treatment options are available. It recognizes the urgent need for patients to receive investigational therapies under certain conditions, even if they do not fulfill the criteria to participate in formal clinical trials.

The act sets forth guidelines for the compassionate use of investigational drugs, ensuring that these products can be utilized safely and responsibly. This access helps to bridge the gap for patients seeking new treatment avenues while the drug is still undergoing the necessary phases of clinical testing.

While options concerning the restriction of drug trials, expediting the approval process, and fully informing patients of drug risks may seem relevant to the broader context of drug development and patient safety, they do not encapsulate the specific aim of the Treatment and Use of Investigational New Drug Act, which focuses on providing investigational drugs to non-trial patients.