The FDA has an accelerated approval mechanism for new drugs. Is FDA Accelerated Approval a Good Thing? Maybe yes. This consent mechanism is in place to help patients with certain serious diseases.
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Because the phrase says that FDA expedited approval involves faster approval than expedited approval. To get expedited approval, sponsors must submit their application to the FDA. Before accepting a permit application, two main checks, described below, are carried out.
MEDICINES SHOULD AIM FOR SERIOUS CONDITIONS
It is a disease or condition that has a significant impact on a person's daily ability to function or even dies. A clinical evaluation must be carried out to determine whether the disease is severe or not.
Assessment is based on the effect of disease on factors such as patient survival and daily functioning. It also assesses the likelihood that the disease will get worse if left untreated.
All life-threatening diseases are classified as major diseases, but do not necessarily have the accelerated FDA approval, as we will see later.
DRUGS MUST BE FOR MEDICAL REQUIREMENTS NOT USED
The term "unmet medical need" is used to refer to a medical condition for which there is no adequate treatment or diagnosis. It can be used to treat cancer or as a way to better and faster diagnose serious illnesses. The use of the term "unmet medical need" can be very broad.
The term "unmet medical need" can be used when appropriate treatment is not available for the patient.