What is one of the key criteria for a drug to be considered eligible for accelerated approval?

To qualify for accelerated approval, the drug must treat a serious condition and generally provide a meaningful advantage over available therapies and demonstrate an effect on a surrogate end point that is reasonably likely to predict clinical benefit or on an intermediate clinical end point that can be measured …

How is the effectiveness of a new drug determined?

Clinical significance of new drugs is more reliably assessed by evaluating absolute risk reduction and the number needed to treat than by evaluating only relative risk reduction data.

How fast is FDA fast track?

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

What dictates the efficacy of a medicine?

In pharmacology, efficacy describes the maximum response that can be achieved with a drug. The effect of the drug is plotted against dose in a graph, to give the dose–response curve. The increasing doses used are displayed by the X axis and the half maximal and maximal responses are displayed by the Y axis.

How is efficacy measured in clinical trials?

Thus, efficacy is measured under expert supervision in a group of patients most likely to have a response to a drug, such as in a controlled clinical trial. Often, a drug that is efficacious in clinical trials is not very effective in actual use.

How fast can FDA approval take?

Priority Review means that FDA aims to take action on an application within six months, compared to 10 months under standard review. A Priority Review designation directs attention and resources to evaluate drugs that would significantly improve the treatment, diagnosis, or prevention of serious conditions.