RPI Blog 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: A drug and a biologic; for example, a therapeutic drug combined with a monoclonal antibodyA drug and a device, such as an insulin injector penTwo drugs and a device;Read moreThe post Using the 505(b)(2) Pathway to Streamline Regulatory Approval for Combination Products appeared first on Regulatory Professionals.