Guidelines on Fixed Dosage Combinations (FDCs): A Review

Authors: Gill SS*

DOI: 10.23880/beba-16000197

Volume 7, Issue 1

Abstract

Combination products, also known as fixed dose drug combinations (FDCs), are a combination of two or more active pharmacological components. In the US, the Food and Drug Administration defines a "product" as "any combination of a drug and a tool or a biological product." Regulatory Bodies, such as CDSCO, have laid down various rules and regulations on FDCs and classify them into four different types based on their origin status and have laid down requirements for FDCs under schedule Y and New Clinical Trials Rules 2019 along with rules such as rule 80.

Keywords: Generic Drugs; Pharmaceutical Industry; Regulatory; Guidelines; Fixed Dose Combinations; CDSCO; FDA Guidelines on FDCs

View PDF