by Frank Sorce | May 4, 2022 | Blog, Drug Development Consulting
May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager In May of 2014 and February of 2019, the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and...
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 | Apr 20, 2018 | Blog, Drug Development Consulting, Regulatory Affairs
April 20, 2018 | Kasturi Puranam, PhD | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting I hope that you have read our previous blog posts on IND filing and have learned about the types of INDs, when you need to file an IND, and pre-IND...
by Frank Sorce | Mar 14, 2018 | Blog, Drug Development Consulting, Regulatory Affairs
March 14, 2018 | Preeti Chugha, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting You’ve determined that you need to file an IND to conduct human trials in the US. What do you need to do before you submit your IND? While INDs...
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...
by Frank Sorce | Feb 10, 2016 | Blog, Drug Development Consulting, Gilbert “Chip” W. Carnathan, Regulatory Affairs
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...
