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...
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...
January 10, 2022 | Julia DiFiore, PhD | Clinical Research Scientist Many of us involved with drug development derive a lot of satisfaction in knowing that our work contributes to improving the health of patients around the globe. As professional drug development...
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...
October 30, 2019 | Brandi Schuster, PhD, Clinical Research Scientist | Medical Writing Services So you’ve decided to begin a career in medical writing – congratulations! Now what? It may be scary leaving the comfort of your lab and pipettes, and medical writing...
February 25, 2019 | Cheryl Ainslie, PhD, Clinical Research Scientist II | Regulatory Affairs Services In a previous post, I summarized the process by which the International Council for Harmonisation (ICH) creates harmonized guidelines for use by the pharmaceutical...
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