Full NDA Approval Without Conducting Any Clinical Studies Using The 505(B)(2) Pathway
Full NDA Approval Without Conducting Any Clinical Studies Using The 505(B)(2) Pathway
1 PagesThe Global 505(b)(2) Experts CamargoPharma.com | 9825 Kenwood Road Cincinnati, OH 45242 USA | (513) 561-3329 Case Study 4 Case Study 4: Full NDA approval without conducting any clinical studies using the 505(b)(2) pathway Challenge: A Literature-only NDA. Eliminate the need for clinical studies for a fixed dose combination product. Background: Client wanted to leverage the significant public knowledge abo
