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FDA’s Expedited Programs and Their Impact on the Availability of New Therapies

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Abstract

The US Food and Drug Administration’s (FDA’s) Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy programs have been successful in facilitating the drug approval process and getting medications to patients quicker. To qualify for one or more of these FDA programs, a sponsor must meet specific criteria. Once a drug is given one or more designations, benefits can range from frequent meetings with FDA representatives to appointed FDA senior managers to facilitate the approval process. This paper will review the major guidelines set forth by the FDA, highlight advantages to the patient and health care community as a result of receiving specific designations, and provide several examples for illustration. As a result of these designations, many patients with rare diseases or life-threatening conditions have been afforded earlier access to effective therapies. As the pharmacist’s role continues to expand, it is crucial to understand the nature of these accelerated programs and to advocate for increased access to new drug therapies.

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Authors and Affiliations

  1. Ernest Mario School of Pharmacy Rutgers University, 160 Frelinghuysen Road, Piscataway Township, NJ, 08854, USA

    Nehar Damle PharmD(cand), Shilvi Shah PharmD(cand), Praneeta Nagraj PharmD & Pardis Tabrizi PharmD

  2. Pfizer Inc, New York, NY, USA

    Praneeta Nagraj PharmD, Pardis Tabrizi PharmD, Gustavo Enrique Rodriguez PharmD & Rahul Bhambri PharmD

Authors
  1. Nehar Damle PharmD(cand)
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  2. Shilvi Shah PharmD(cand)
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  3. Praneeta Nagraj PharmD
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  4. Pardis Tabrizi PharmD
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  5. Gustavo Enrique Rodriguez PharmD
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  6. Rahul Bhambri PharmD
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Corresponding author

Correspondence to Nehar Damle PharmD(cand).

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Damle, N., Shah, S., Nagraj, P. et al. FDA’s Expedited Programs and Their Impact on the Availability of New Therapies. Ther Innov Regul Sci 51, 24–28 (2017). https://doi.org/10.1177/2168479016666587

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  • DOI: https://doi.org/10.1177/2168479016666587

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