February 15, 2024February 16, 2024 | Yash Patel, PharmD, Yamini Purohit, PhD, and Kelsey Gray, PhD – Medical Writing Fellows | Medical…
February 8, 2024Selecting a Contract Development and Marketing Organization (CDMO) is not a new topic, and much has been written and learned…
January 16, 2024Our team of medical writers has worked with many clients on marketing applications (e.g., NDA, ANDA, BLA, or MAA)…
January 10, 2024Whether it’s a clinical study report (CSR) for a single clinical study or a Clinical Overview that summarizes a…
September 28, 2023The IND Filing Process and Categories Federal law mandates that drugs have an approved marketing application for interstate transport,…
July 7, 2023Personalized medicine is truly that. Based on an individual's unique genetic profile, it’s used to make precise decisions according to…
April 27, 2023It’s imperative that biopharma organizations developing innovative treatments for rare diseases navigate the FDA’s Orphan Drug Designation (ODD) program. Since…
May 4, 2022May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager In May of 2014 and February of 2019, the FDA…
January 10, 2022January 10, 2022 | Julia DiFiore, PhD | Clinical Research Scientist Many of us involved with drug development derive a…
June 2, 2020June 2, 2020 | Kathryn Tworkoski, PhD, RAC | Principal Clinical Research Scientist In the past, we’ve written blog posts…
