Tag: 505(b)(2)

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: A drug and a...

Medical and Regulatory Affairs

ANDA or 505(b)(2): Choosing the Right Abbreviated Approval Pathway for Your Drug

For developers seeking to obtain approval for previously approved drug products in the United States, the U.S. Food and Drug Administration (FDA) offers two abbreviated approval pathways — an abbreviated new drug application (ANDA) and a 505(b)(2) application. Both of these applications rely on the agency’s finding of safety and effectiveness for a listed drug,...