Latest Developments and Insights

August 25, 2016 | Kim Nice, PhD, Associate Director, Medical Writing and Submissions Management | Medical Writing Services In previous posts, you were introduced to the role of regulatory medical writing and heard about the day-to-day activities of a regulatory…

March 10, 2016 | Kathryn Tworkoski, PhD, Clinical Research Scientist | Regulatory Affairs, Medical Writing Services, Drug Development Consulting Everyone knows that getting FDA approval of a new drug, whether it be a new molecular entity (NME) approved through a…

February 25, 2016 | Tim Garver, PhD, Executive VP and Chief Operating Officer | Medical Writing Services You’re finally there! You and your colleagues find yourself at the doorstep of being able to submit either a New Drug Application (NDA)…

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…