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Drug Regulation and Oversight, from Local to Global

  • Perspective
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Abstract

Purpose

The purpose of this perspective piece is to address the potential for drug and medical product innovation through sound regulation and strengthened international harmonization.

Methods

Current literature, recommendations and guidelines in regulatory agencies assisted in this perspective review.

Results

Multiple guidelines and recommendations provide for strategic planning and process improvement capabilities at local, national and international levels.

Conclusions

Seeking best practice starts with identifying and improving individual nation drug regulatory bodies, including the US Food and Drug Administration (FDA). Inefficiency causes and process improvement solutions have been suggested and outlined in strategic plans at the FDA as well as with multiple stakeholder organizations and public-private partnerships. Cohesively, these groups should be tasked with formal, consistent updates on improvement as well as ongoing supportive research and evaluation of the changes implemented. Simultaneously, the international community has a tremendous opportunity to act on best practice for drug and medical product innovation by aligning sound and consistent approach to regulation.

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Authors and Affiliations

  1. 415 Herondo St., Apt 332, Hermosa Beach, CA, 90254, USA

    Julie Babyar

Authors
  1. Julie Babyar
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Correspondence to Julie Babyar.

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There are no conflicts of interest to declare.

Human and Animal Rights and Informed Consent

This article does not contain previously unpublished studies with human or animal subjects performed by any of the authors.

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Babyar, J. Drug Regulation and Oversight, from Local to Global. J Pharm Innov 12, 185–187 (2017). https://doi.org/10.1007/s12247-017-9280-2

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  • DOI: https://doi.org/10.1007/s12247-017-9280-2

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