PRE-APPROVAL ACCESS POLICY

65 Grove Street

Watertown, MA 02472

 

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. The information below explains options that may be available to patients in these circumstances.

 

1. Clinical Trials

For new medicines and vaccines to be legally approved for use, companies 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 and patient “informed consent” is a required step in the process of enrolling.

For more information about Lyndra clinical trials, see Clinical Trials.Gov.

 

2. Pre-Approval Access

When a clinical trial isn’t an option, and the patient has exhausted all available treatment options, there may be an opportunity for a treating physician to request an investigational drug pre-approval. Lyndra refers to these requests as pre-approval access.

It’s important to remember that investigational drugs have not yet received regulatory approval. Their potential risks and benefits are not yet established. Doctors and patients should consider all possible benefits and risks when seeking pre-approval access to an investigational drug.

Request information about pre-approval access for a Lyndra investigational drug here.

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