FDA has implemented several policies and programs to accelerate the process of drug marketing, including:
Breakthrough Therapy Designation: This designation is given to drugs that have shown significant improvement in treatment for life-threatening or irreversibly debilitating diseases. It allows for expedited review and potentially shorter development timelines.
Fast Track Designation: This designation is given to drugs that are intended to treat serious conditions and demonstrate the potential to address unmet medical needs. It allows for more frequent meetings with the FDA and may lead to priority review at the time of submission of a marketing application.
Accelerated Approval: This pathway allows for earlier approval of drugs for serious conditions based on surrogate endpoints reasonably likely to predict clinical benefit. The FDA requires post-marketing studies to verify the anticipated clinical benefit.
Regenerative Medicine Advanced Therapies (RMAT) Designation: This designation is given to regenerative medicine therapies intended to treat serious conditions. It provides for close collaboration between the sponsor and the FDA during product development and review.
Orphan Drug Designation: This designation is given to drugs intended to treat rare diseases or conditions affecting fewer than 200,000 people in the United States. It offers incentives such as tax credits and market exclusivity for a limited period.