- Priority Review: The FDA intends to take action on an application within 6 months for products intended to treat serious diseases which demonstrate a significant improvement in safety, effectiveness, prevention or diagnosis of a condition.
- Fast Track: Enables more frequent meetings and written communication with the FDA, eligibility for Accelerated Approval and Priority Review and a rolling review of the New Drug Application. Drugs which demonstrate superior effectiveness on serious outcomes, avoid serious side effects of an available therapy, improves diagnosis, decreased clinically significant toxicity and/or address an emerging or anticipated public health need may apply for Fast Track designation.
- Breakthrough Therapy: Under this designation, a drug benefits from all the feature of Fast Drug drugs, in addition to guidance for developing an efficient drug development program as well as organizational commitment involving senior managers. This designation is intended for drugs which treat serious conditions and have an effect on an established surrogate or intermediate clinical endpoint, on a pharmacodynamic biomarker, and/or has a significantly improved safety profile.
- Accelerated Approval: Allows drugs to be improved based on a surrogate endpoint or an intermediate clinical endpoint rather than a clinical endpoint which may take much longer to see results.