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A Guidance on Premarket Pathways for Combination Product in the United States of America

1, 2★, 1, 1, 1★ Corresponding author

  1. 1Department of Pharmaceutics and Regulatory Affairs, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.
  2. 2Department of Pharmaceutics and Regulatory Affairs, CORMIL and CMPAT, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.

CORRESPONDENCE

Vedamurthy Joshi

Department of Pharmaceutics and Regulatory Affairs, CORMIL and CMPAT, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.

vedamurthyjoshi@gmail.com

Received: 06-05-2022; Revised: 23-07-2022; Accepted: 30-08-2022.

Volume 12, Issue 4 · pp. 403-407 · 2022 · DOI: 10.5530/ijpi.2022.4.70

ABSTRACT

The Office of combination products OCP, an agency to regulate the combination products under the US Food and Drug Administration (FDA) has released the final guidance on the combination products for its approval which is named “Principles of Premarket Pathways for Combination Drugs,” which provides the FDA’s current strategies on the approval of combination products into the market. The final guideline, which is comparable to the draft notification issued in February 2019, emphasizes and specifies the five particular instances in which those techniques apply.

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    SU, V., Joshi, V., Goudanvar, P., Banerjee, S., & S, V. P. (2022). A Guidance on Premarket Pathways for Combination Product in the United States of America. International Journal of Pharmaceutical Investigation, 12(4), 403-407. https://doi.org/10.5530/ijpi.2022.4.70

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    © 2022 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. CC BY-NC-SA 4.0