Process and Regulations of Fast Track

  New pharmacological agents go a long way in clinical trials and approvals from the Food and Drug Administration before entering a wide market and becoming available to needy patients in the United States. At the same time, for promising drugs that can significantly improve the results of existing therapy or fill a missing niche, this process can be accelerated using the Fast Track protocol (Woo & Robinson, 2015). The latter provides for the filing of a special application by a pharmacological company at the FDA office, which the latter examine within 60 days. If the medicine acquires Fast Track status, manufacturers receive a number of concessions, such as the right to more frequent correspondence and meetings with representatives of this state regulatory body and the possibility of cooperation in conducting a clinical trial. If convincing positive results are obtained, it is possible to obtain FDA approval after a single phase 2 clinical trial (Papadimitriou & Butler, 2017). In addition, the verification process of such a pharmacological agent is significantly reduced from 10 to 6 months.

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