Latest Developments and Insights

February 18, 2016 | B J. Witkin, Senior Manager | Regulatory Operations I recently attended the DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) forum, an annual conference for people who work in Regulatory Operations and Regulatory Information. As usual,…

February 10, 2016 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting Yeah, yeah, we know. The general public considers biosimilars to be “generic” versions of approved biological products. The FDA has gone to great…

February 4, 2016 | BJ Witkin, Senior Manager | Regulatory Operations One of the biggest challenges of publishing an NDA, MAA or BLA is dealing with the clinical summaries: the Summary of Clinical Safety (SCS), the Summary of Clinical Efficacy…

August 20, 2015 | Mark Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs We’ve all seen or heard them – either in popular magazines and newspapers or on television and radio – advertisements directed to us, the consumers of…