Rebecca Dandeker Discusses FDA Final Guidance on Overhauled OTC Monograph System with HBW Insight

Rebecca L. Dandeker, partner in the Food & Drug Practice, was extensively quoted by HBW Insight in the article, "US OTC Monograph Guidance On Formal Meetings Adds IND Studies, Clarifies ‘Joint’ Requests," where she discussed the Guidance's updates and implications for industry. "It is always useful for industry members to have a written description of FDA's expectations with respect to meeting requests, submission formats, FDA definitions and now, joint meeting limitations, for industry planning purposes on development timelines, resources, guardrails, and confidentiality protections," noted Dandeker.