Overview of FDA Expedited Development and Approval Programs for Serious Conditions
Impact Pharmaceutical Services
MAY 4, 2022
Abbreviations: BLA= Biologics License Application; IND= Investigational New Drug; NDA= New Drug Application; RMAT= Regenerative Medicine Advanced Therapy. *A For example, a drug that has received breakthrough therapy designation or fast track designation can be eligible for the accelerated approval pathway, if relevant criteria are met.
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