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Compassionate Use & Expanded Access
365体育足球Patients facing serious illnesses who have exhausted all available treatment options often want to know if and how they can receive early access to investigational drugs that haven’t yet been approved by government regulatory agencies. This below explains options that may be available to patients in these circumstances.
1. Clinical Trials
365体育足球For new medicines and vaccines to be legally approved for use, companies like Pfizer are required to evaluate their safety and effectiveness in clinical trials and submit trial results to regulatory agencies. To participate in a trial, you must meet certain criteria. For those who meet the criteria to join a clinical trial, participation offers the chance to contribute to medical research that may benefit many others. Participation in a clinical trial comes with certain risks; that is why “informed consent” is a required step in the process of enrolling.
2. Compassionate Use, or Expanded Access (“Compassionate Access”)
In cases where a clinical trial isn’t an option, and the patient has exhausted all available treatment options, regulators may grant permission for us to provide a treating physician with an unapproved drug. Such individual use of an unlicensed investigational drug is often called “compassionate use” or “expanded access” but may go by other names. Pfizer refers to these uses collectively as “compassionate access.”
365体育足球It’s important to remember that investigational drugs have not yet received regulatory approval; therefore, their potential risks and benefits are not yet established. Doctors and patients should consider all possible benefits and risks when seeking compassionate access to an unapproved product.
365体育足球Please feel free to with any questions.