Regulatory Prospective about Combination Products in USFDA

Rajole  Pratiksha R.; Sawant  Prerana P.; Dhopare  Mahesh R.; Kashid  Girish A.

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Published: Apr 7, 2023

Keywords:

combination product RFD OCP

Rajole Pratiksha R.

Student M. Pharm- Drug Regulatory Affairs Sanjivani College of Pharmaceutical Education and Research. Kopargaon, Ahmednagar, Maharashtra, India.

Sawant Prerana P.

Student M. Pharm- Drug Regulatory Affairs Sanjivani College of Pharmaceutical Education and Research. Kopargaon, Ahmednagar, Maharashtra, India.

Dhopare Mahesh R.

Student M. Pharm- Drug Regulatory Affairs Sanjivani College of Pharmaceutical Education and Research. Kopargaon, Ahmednagar, Maharashtra, India.

Kashid Girish A.

Head of the Department, Pharmaceutical Chemistry Sanjivani College of Pharmaceutical Education and Research. Kopargaon, Ahmednagar, Maharashtra, India.

Abstract

All healthcare goods in the pharmaceutical sector are classified as Drugs, Devices, and Biologics, and they are governed by their respective regulatory authorities. In the current context, Science and technological advancements have led to the development of innovative novel items in the healthcare sector. More accurate illness identification and treatment, as well as the growth of these revolutionary technologies, have resulted in a blurring of the lines. Due to historical distinctions between healthcare products, these developments gave rise to products with merged features. A regulation about combination products and the FDA's perspective. The article discusses guidelines regarding the combination product and what are the challenges that occur to regulate combination products

How to Cite

Pratiksha R., R. ., Prerana P., S. ., Mahesh R., D. ., & Girish A. , K. . (2023). Regulatory Prospective about Combination Products in USFDA. Journal of Coastal Life Medicine, 11(1), 1533–1538. Retrieved from https://www.jclmm.com/index.php/journal/article/view/553

Issue

Vol. 11: Number 1, 2023

Section

Articles

References

Requesting FDA feedback on combination products. FDA. s.l.: U.S department of health and human serices, 2020.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=3.2

Uemura N, Kasanuki H, Umezu M. New Visualization Models of Designation Pathway and Group Categorization of Device-Drug and Device-Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions. Ther Innov Regul Sci. 2021 Jul;55(4):807-817. doi: 10.1007/s43441-021-00276-x. Epub 2021 Apr 12. PMID: 33844189; PMCID: PMC8238755.

Principles of Premarket Pathways for Combination Products

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/principles-premarket-pathways-combination-products

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/application-user-fees-combination-products#userfees

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-write-request-designation-rfd

https://www.fda.gov/combination-products/about-combination-products/frequently-asked-questions-about-combination-products#examples

Post marketing safety reporting for combination products https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products

How to request Pre-RFD

https://www.fda.gov/media/102706/download

https://www.fda.gov/combination-products/about-combination-products/combination-product-definition-combination-product-types