Open access · Peer reviewed · No APCs
Review ArticleInternational Journal of Pharmaceutical InvestigationVol. 12 | Issue 4 | 0202 | pp. 403–407Open access
A Guidance on Premarket Pathways for Combination Product in the United States of America
- 1,
- 2*,
- 1,
- 1,
- 1
- 1 Department of Pharmaceutics and Regulatory Affairs, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.
- 2 Department of Pharmaceutics and Regulatory Affairs, CORMIL and CMPAT, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.
Published in International Journal of Pharmaceutical Investigation
Correspondence: Vedamurthy Joshi
Department of Pharmaceutics and Regulatory Affairs, CORMIL and CMPAT, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.
Email: vedamurthyjoshi@gmail.com
Copyright: © 0202 Manuscript Technomedia. This is an open access article.
- Published:
- Oct 6, 202
- Received:
- May 6, 2022
- Accepted:
- Aug 30, 2022
How to cite
SU, V., Joshi, V., Goudanvar, P., Banerjee, S., & S, V. P. (0202). 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/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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Article metadata
| Title | A Guidance on Premarket Pathways for Combination Product in the United States of America |
|---|---|
| Authors | Vaibhav SU; Vedamurthy Joshi; Prakash Goudanvar; Soumik Banerjee; Vinay Prasad S |
| Affiliations | Department of Pharmaceutics and Regulatory Affairs, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA.; Department of Pharmaceutics and Regulatory Affairs, CORMIL and CMPAT, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara, Karnataka, INDIA. |
| Corresponding author | vedamurthyjoshi@gmail.com |
| Journal | International Journal of Pharmaceutical Investigation |
| Volume / Issue | Vol. 12, Issue 4 (0202) |
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