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

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Review · Volume 12, Issue 4 · pp. 403–407

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

Vaibhav SU1, Vedamurthy Joshi2, Prakash Goudanvar1, Soumik Banerjee1, Vinay Prasad S1

  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.

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.

Keywords: Combination products; Premarket pathway for NDA; ANDA; 510K and Denovo

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