What is to know about Four major FDA programs?

In May 2014, the United States Food and Drug Administration published guidance on four accelerated programs of serious diseases for small molecule drugs and biologics. According to the FDA, the purpose of this guide is to facilitate and accelerate the development, review and approval of new drugs to address unmet medical needs for the treatment of serious or life-threatening diseases. According to FDA guidance, an unmet medical need is a condition whose treatment or diagnosis is not adequately addressed by current available therapy.

Types of FDA programs

The four FDA programs are classified into – fast track designation, breakthrough therapy designation, accelerated approval and priority review designation. The first two are generally used in early drug development. However, FDA fast track designation applies to a drug that is intended to treat a serious condition, and non-clinical and clinical data demonstrate the potential to address the unmet medical need. Priority review is used for Biologics license application, and NDA (New drug application) submissions. The accelerated approval is necessary during the review of the BLA and NDA. FDA issued new guidance to include a new accelerated program called “Regenerative Medicine Advances Therapy Designation”.

Aspects to consider

An important point to keep in mind is that the drugs that apply to FDA expedited programs are those that have an effect on a serious condition or on a serious aspect of a condition, such as a direct effect on the symptom of a disease or other effects.

• A diagnostic product intended to improve the diagnosis or detection of a serious condition,

• A product intended to mitigate or prevent a serious side effect related to treatment,

• A product intended to prevent or lessen a serious adverse event associated with available therapy,

• A product intended to prevent a serious condition or a more advanced stage of the disease.

Conclusion

The advantages of these accelerated programs are that they allow frequent interactions with intensive guidance, with the FDA review team and the requesting company. Throughout the process, FDA will seek to ensure that a drug sponsor applying to these programs receives timely advice and frequent interactive communications to help the sponsor design and conduct a drug development program in the most efficient manner possible. We must bear in mind that these designations once approved, the FDA can revoke them as long as the designation no longer meets the qualification criteria. All these regulations will allow us to have more treatments for unmet medical needs in the shortest possible time.

Source: https://www.bloglovin.com/@aaryan27/what-is-to-know-about-four-major-fda-programs