Fast Track and Orphan drug

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What are the benefits of Fast Track FDA?
Drugs that receive Fast Track Designation from the FDA are eligible for some or all of the following benefits: More frequent meetings with the FDA. More frequent written communication with the FDA. Eligibility for Accelerated Approval and Priority Review if criteria are met.Mar 29, 2022

What is the FDA guidance on orphan drugs?
The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including: Tax credits for qualified clinical trials. Exemption from user fees.Jul 8, 2022

What is the exclusivity period for orphan drugs in US?
The exclusivity granted to orphan drugs provides seven years without generic competition for the approved orphan designation but does not prevent generic competition for other approved uses of the medicine.