by Don McLean | Jun 13, 2019 | Blog
Developing Treatments for Rare Diseases – Reviewing Draft Guidance from the FDA by Amanda Beaster, PhD, Andrew Chervenak, PhD, Halina Chkourko Gusky, PhD, and Ingrid Hansen, MS New and updated regulatory guidances from the US Food and Drug Administration (FDA),...
by Don McLean | Feb 28, 2019 | Blog
How #OneMMS Actively Supports Rare Disease Day by Staff writer Rare diseases are often overlooked, but they affect many individuals. There may be as many as 7,000 rare diseases affecting approximately 25-30 million people in the US alone, according to the National...
by Don McLean | Jan 31, 2019 | Uncategorized
Tips for Nonclinical Pharmacology and the Medical Writers that Draft Regulatory Submissions by September Mihaly, Ph.D., RAC Summarizing nonclinical studies in Module 2.6 of the common technical document (CTD) takes a unique skillset. These studies include...
by Don McLean | Jan 3, 2019 | Blog
One Manager’s Career Path: Reflections of a Laboratory Scientist in Drug Development by Amanda Beaster, Ph.D. In the early 2000s, I sat in an undergraduate microbiology lab and caught the bug. It was not a laboratory-acquired infection, but inspiration from a world...
by Don McLean | Jul 26, 2018 | Blog
The Federal Food, Drug, and Cosmetic Act (FDCA) is Still Relevant and Evolving by Christine Tervo, MS Last month, the Federal Food, Drug, and Cosmetic Act (FDCA) turned 80 years old. On June 25, 1938, the FDCA was signed by President Franklin Roosevelt. It was passed...
