FDA Development Paths
1️⃣ Standard Designation: Standard designation is the typical pathway for drug development, involving preclinical studies and three phases of clinical trials to assess safety and efficacy thoroughly.
2️⃣ Orphan Designation: Reserved for drugs targeting rare diseases, this designation offers incentives like tax credits and marketing exclusivity to encourage development for underserved patient populations.
3️⃣ Fast Track Designation: Fast Track expedites drug development for serious conditions with unmet medical needs, allowing more frequent interactions with the FDA and potential for accelerated approval.
4️⃣ Accelerated Approval: Granted based on surrogate endpoints for serious conditions with no effective treatments, this pathway enables quicker market access, with post-marketing studies required to confirm clinical benefits.
5️⃣ Priority Review: Reserved for drugs offering significant improvements over existing therapies for serious conditions, Priority Review aims to complete the FDA review within six months, expediting access to promising treatments.
6️⃣ Breakthrough Therapy Designation: Reserved for drugs showing substantial improvement over existing therapies, Breakthrough Therapy status expedites development with FDA guidance, aiming to bring innovative treatments to patients faster.
Source: Nicolas Hubacz via Camila Fedi on the HR App!
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