Understand the FDA's Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations for expediting drug approvals.

Facilitating Priority Review of Drugs: FDA Designations to Streamline and Prioritize the Review of Drugs and Therapies

One of the fundamental priorities of public health is to ensure timely access to treatments to combat devastating diseases. In this regard, the United States Food and Drug Administration (FDA) has established four strategic programs to streamline the development and review of drugs that represent a significant advancement in medical care.

Fast Track

Fast Track is a comprehensive program designed to expedite the development, submission, and review of drugs targeting serious diseases with an unmet medical need.

Breakthrough Therapy

Breakthrough Therapy designation is granted to drugs intended to treat severe diseases with unmet medical needs. It is based on preliminary evidence suggesting a substantial improvement in clinical outcomes compared to available treatments.

Accelerated Approval

Accelerated Approval enables early marketing of drugs for serious diseases that address a critical medical need. It is based on surrogate markers of efficacy (indirect endpoints), such as tumor size reduction, rather than waiting for confirmation of long-term clinical benefit (increased survival).

Priority Review

Priority Review focuses on accelerating the evaluation process for drugs that exhibit promising therapeutic potential compared to existing alternatives. The FDA commits to issuing a decision within 6 months of receiving the application.

It is crucial to emphasize that while these programs allow for a more expedited evaluation of drugs, they do not compromise the required safety and efficacy standards. The FDA requires subsequent confirmatory studies to ensure long-term clinical benefit.

Source: #FDA

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