Combination Products Resources

Fixed-Dose Combination Products – Navigating the Combination Rule

Fixed-dose combination products (FDCs), or drugs containing multiple active ingredients, offer benefits to pharmaceutical companies and patients. For Pharma, creative matching of multiple APIs can open new markets, while for patients, FDCs can offer convenience and therapeutic benefits. Often, FDCs are composed of previously approved agents, and the 505(b)(2) pathway is commonly used for these […]
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How Many FDA Premarket Applications Are Necessary For Your Combination Product?

This week, we are pleased to share an article written by Camargo Pharmaceutical Services’ new Medical Device expert, Dr. Girish Kumar, along with Dr. P.K. Narang, and published by Pharmaceutical Online, Med Device Online, and Bio Process Online. How Many FDA Premarket Applications Are Necessary For Your Combination Product? Often, an already-approved drug can further […]
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