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

  • Vaibhav SU Department of Pharmaceutics and Regulatory Affairs, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.
  • Vedamurthy Joshi Department of Pharmaceutics and Regulatory Affairs, CORMIL and CMPAT, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.
  • Prakash Goudanvar Department of Pharmaceutics and Regulatory Affairs, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.
  • Soumik Banerjee Department of Pharmaceutics and Regulatory Affairs, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.
  • Vinay Prasad S Department of Pharmaceutics and Regulatory Affairs, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.
Keywords: Combination products, Premarket pathway for NDA, ANDA, 510K and Denovo, etc.,

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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A Guidance on Premarket Pathways for Combination Product in the United States of America
Published
2022-10-01
How to Cite
1.
SU V, Joshi V, Goudanvar P, Banerjee S, S VP. A Guidance on Premarket Pathways for Combination Product in the United States of America. ijpi [Internet]. 1Oct.2022 [cited 10Dec.2022];12(4):403-7. Available from: https://www.jpionline.org/index.php/ijpi/article/view/1477