Drugs approved by fast track approval

The fast track designation is reserved for drugs that have shown a potential improvement in efficacy over currently approved therapies for

Currently, there are no Food and Drug Administration (FDA)-approved medicines designed to treat radiation poisoning. Protectan was fast tracked

The CDER Fast Track (FT) Approvals reports contain a list of approvals for fast track designated drugs. New reports will be published in

CDER granted Fast Track status to 12 of the 37 novel drugs (32%) approved in 2024. Fast Track speeds development and review of new drug and biological products by increasing the level of

Many drugs approved by the FDA never become available or are very Accelerated approval and fast track are two different methods.

Between 20, China approved just over 100 new drugs, whereas developed countries approved 433. Cyranoski, D. China announces plans to fast-track drug approval. Nature (2024). https

The first NPC drug approved by the FDA, MIPLYFFA is designation, and Fast Track designation by the FDA for the treatment of NPC.

In the INSA rare disease workshop (2024), the honorable drug controller general of India stated that a policy for accelerated clearance of orphan drugs and fast-track approval is not in place because government needs clear-cut recommendations regarding the definition of rare disease, mechanism for fast-track approval (e.g, waiver of a specific

The CDER Fast Track (FT) Approvals reports contain a list of approvals for fast track designated drugs. New reports will be published in January, April, July