The FDA is attempting to help the drug industry bring the most vital drugs to market in shorter time with programs that include: Fast Track, Priority Review, Breakthrough Therapy Designation and Accelerated Approval. The benefits of Fast Track include scheduled meetings to seek FDA input into development as well as the option of submitting a New Drug Application in sections rather than submitting all components at once. The Fast Track designation is intended for drugs that address an unmet medical need, but is independent of Priority Review, Breakthrough Therapy Designation and Accelerated Approval. Priority drugs are those considered by the FDA to offer improvements over existing drugs or to offer high therapeutic value. The priority program, along with increased budget and staffing at the FDA, is having a positive effect on total approval times for new drugs. Breakthrough therapies show early clinical evidence of very important improvements over currently available drugs.
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