Tag: combination products

Clinical Research: Phase 1 - Phase 4

Using the 505(b)(2) Pathway to Streamline Regulatory Approval for Combination Products

In recent years, the number of approvals for combination products and 505(b)(2) applications has been rising. Combination products consist of at least two constituent parts, each subject to its own statutory and regulatory requirements. Unlike fixed-dose combination therapies, which consist of drug-drug combinations, combination products can include any of the following: The U.S. Food and...


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 Cures Act and Prescription Drug...