August 7, 2024Authorized by the 21st Century Cures Act , Food and Drug Administration’s (FDA) Oncology Center for Excellence (OCE) was established…
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June 10, 2024A regulatory affairs project manager (RAPM) is a pivotal figure in the compliance and regulatory integrity of products or drug development within…
June 10, 2024Understanding the intricacies of navigating regulatory affairs for clinical trials is pivotal in shaping the path to successful medical research…
April 16, 2024One of the many challenges around developing cell and gene therapy products is establishing representative potency methods. In 2011, the…
April 5, 202405 Apr 2024 | Nate DiTommaso, Rachel Capone, Renee Boerner Have you ever wondered why some companies choose to do…
January 10, 2022January 10, 2022 | Julia DiFiore, PhD | Clinical Research Scientist Many of us involved with drug development derive a…
February 25, 2019February 25, 2019 | Cheryl Ainslie, PhD, Clinical Research Scientist II | Regulatory Affairs Services In a previous post, I…
December 14, 2018December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist │ Regulatory Affairs, Medical Writing, Drug Development Consulting Long-time readers…
April 20, 2018April 20, 2018 | Kasturi Puranam, PhD | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting I hope…
