Accelerated Approval


Accelerated approval refers to the pace at which some drugs can be approved by the FDA. Accelerated approval was first introduced in 1992. If the drug is being produced to meet a serious condition, and it can meet a serious medical need, a drug may qualify for accelerated approval. Of note, there also has to be an objective surrogate endpoint marker such as a physical sign, a radiographic image, or a specific laboratory measurement, that indicates the treatment is working better than currently approved treatments. If a drug meets all of these conditions, then it may reach the open market faster pursuant to FDA approval. Confirmatory clinical trials are still required, and if they show that the drug is indeed working as intended, then the FDA may issue conventional approval on top of the drug’s original accelerated approval.

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