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Combination Products Articles and Insights

PREA and Fixed-Dose Combinations: When Things Get Complicated

The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children. PREA requires new drug applications (NDAs) and biologics license

UPDATE – Draft FDA Guidance Concerning Combination Products

As those working in the development of combination products likely know, the Food and Drug Administration (FDA) issued two new draft guidances in December 2019. The guidances – Requesting FDA Feedback on Combination Products and Bridging for Drug-Device and Biologic-Device Combination Products – were published in response to the 21st Century

Drug Development for an Aging Population

Fueled by unprecedented medical, technological and social advancements of the past century, it should be no surprise that we are living longer than ever before. By 2030, more than one in four people in Europe and North America will be 60 years or older. And

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