by Frank Sorce | Jun 2, 2020 | Blog, Kathryn Tworkoski, Medical Writing, Regulatory Operations
June 2, 2020 | Kathryn Tworkoski, PhD, RAC | Principal Clinical Research Scientist In the past, we’ve written blog posts explaining what an Investigational New Drug (IND) is, providing guidance on pre-IND meetings, and outlining the submission and maintenance of...
by Frank Sorce | Aug 15, 2017 | BJ Witkin, Blog, Regulatory Operations
August 15, 2017 | B J. Witkin, Senior Manager | Regulatory Operations Because IMPACT writes and publishes so many CSRs, we get a lot of sponsors asking us questions about how CSRs should be published. This tells me that there’s a lot of confusion about CSR...
by Frank Sorce | Feb 18, 2016 | BJ Witkin, Blog, Regulatory Operations
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...
by Frank Sorce | Feb 4, 2016 | BJ Witkin, Blog, Regulatory Operations
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 (SCE), the Integrated...