True or False: A treatment protocol detailed for patient use must be submitted to the FDA.

The assertion that a treatment protocol detailed for patient use must be submitted to the FDA is accurate. When a treatment protocol is proposed, especially in the context of investigational new drugs or any new therapies that require regulatory oversight, it's crucial for the FDA to evaluate the safety and efficacy of the treatment. This ensures that any new procedures or protocols involving drugs are aligned with established guidelines and protect patient health.

Typically, any treatment protocol involving an investigational new drug or a new treatment plan that is not yet approved for general use must receive FDA oversight before being implemented in clinical settings. This is part of the FDA's mission to ensure the safety and effectiveness of medical treatments administered to patients. Providing this information allows the FDA to assess potential risks, monitor the integrity of clinical trials, and ensure compliance with regulatory requirements, which consistently aligns with the principles of protecting public health.