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 | Dec 14, 2018 | Blog, Drug Development Consulting, Kathryn Tworkoski, Medical Writing, Regulatory Affairs
December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist │ Regulatory Affairs, Medical Writing, Drug Development Consulting Long-time readers of this blog will recall (with great enthusiasm, I’m sure) our previous posts on rare diseases,...
by Frank Sorce | Feb 16, 2018 | Blog, Drug Development Consulting, Kathryn Tworkoski, Regulatory Affairs
February 16, 2018 | Kathryn Tworkoski, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting Introducing a new therapeutic agent to human patients can be simultaneously exciting and nerve-wracking. Over the years, we’ve had a lot...