Drug Development Consulting
Empowering and Encouraging Innovation: The Advantages of the FDA’s Orphan Drug Designation for Drug Companies and Patients
It’s imperative that biopharma organizations developing innovative treatments for rare diseases navigate the FDA’s Orphan Drug Designation (ODD) program. Since its passage in 1983, the Orphan Drug Act has helped countless individuals living with rare diseases receive...
Overview of FDA Expedited Development and Approval Programs for Serious Conditions
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...
Current Topics in Orphan Drug Development
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,...
Ready to Submit Your Initial IND?
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...
Before you file your IND…
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...
The Ins and Outs of INDs
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...
Formal Meetings with FDA for Biosimilar Products
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...
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