[1] A drug that is made from a living organism or its products undergoes the same approval process but is called a biologics license application (BLA).
In 2018 federal "Right to Try" laws were enacted in the United States, which allows individuals who fit into the criteria to try experimental drugs that are not yet deemed safe.
[2] The FDA has the authority to issue EUAs for medical products, including drugs and vaccines, during public health emergencies.
This mechanism was prominently utilized during the COVID-19 pandemic, allowing for the rapid deployment of vaccines and therapeutics to address the crisis.
The process for EUA includes the determination of a public health emergency, review of available scientific evidence, and consideration of the potential benefits and risks of the product.