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FDA’s Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes

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  • Theme: Celebrating Women in the Pharmaceutical Sciences
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Abstract

Poly (lactic-co-glycolic acid) (PLGA) has been used in many long-acting drug formulations which have been approved by the US Food and Drug Administration (FDA). However, generic counterparts for PLGA products have yet to gain FDA approval due to many complexities in formulation, characterization, and evaluation of test products. To address the challenges of generic development of PLGA-based products, the FDA has established an extensive research program to investigate novel methods and tools to aid both product development and regulatory review. The research focus have been: (1) analytical tools for characterization of PLGA polymers; (2) impacts of PLGA characteristics and manufacturing conditions on product performance; (3) in vitro drug release testing and in vitro-in vivo correlation of PLGA-based products, and (4) modeling tools to facilitate formulation design and bioequivalence study design of PLGA-based drugs. This article provides an overview of FDA’s PLGA research program and highlights scientific accomplishments as well as regulatory outcomes that have resulted from successful research investigations.

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Notes

  1. 21 CFR 314.94(a)(9)(iii)

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Acknowledgements

The authors would like to thank all of the awarded project research collaborators that have contributed to the success of the PLGA research program.

Disclaimer

This article reflects the views of the authors and should not be construed to represent the views or policies of the US Food and Drug Administration (FDA).

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Author notes

  1. Stephanie H. Choi

    Present address: Greenwich Biosciences, Inc., Carlsbad, California, USA

Authors and Affiliations

  1. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Silver Spring, 20993, Maryland, USA

    Yan Wang, Bin Qin, Grace Xia & Stephanie H. Choi

Authors
  1. Yan Wang
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  2. Bin Qin
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Correspondence to Yan Wang.

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Guest Editors: Diane Burgess, Marilyn Morris and Meena Subramanyam

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Wang, Y., Qin, B., Xia, G. et al. FDA’s Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes. AAPS J 23, 92 (2021). https://doi.org/10.1208/s12248-021-00611-y

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