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FDC Guidelines for Pharmaceutical Approval by gpg19751215 is a document available to read on EtoBox.

This document provides guidelines on the data required for approval of fixed dose combination (FDC) drugs in India. It divides FDCs into different categories based on their marketing and approval status. For FDCs with an unapproved new drug, complete pre-clinical and clinical data is required, similar to a new chemical entity. For FDCs with approved ingredients, lesser data from literature or previous trials may suffice depending on the specific FDC category. The guidelines aim to establish a risk-based app

Author

gpg19751215

Language

EN