Accelerated Access to New Drug Therapies

The FDA will not approve other versions of the product for orphan-designated use for a period of 7 years after the first approval, provided that an adequate supply of the product is maintained on the U S market. 

The time required to fully establish the safety and efficacy of a new drug in the eyes of the regulatory authority might not always be to the benefit of the proposed patient group. This is particularly so in the case of drugs intended to treat serious or life-threatening diseases where no effective therapy currently exists. Various provisions have been incorporated into the regulations to allow accelerated access to such therapies. 

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