
This Women’s History Month, GLOBAL employees will highlight how women revolutionized science and medicine. In this blog post, Tracy Janus, Sr. VP of Regulatory Affairs & CMC, shares how century-old advice from Florence Nightingale helped us through the largest public health threat our generation has had to face.
Florence Nightingale (1820 – 1910) changed the face of nursing and healthcare globally and is regarded as the mother of modern nursing. She contributed significantly to the establishment of nursing as a respected profession for women. Her most famous book is titled "Notes on Nursing: What It Is, and What It Is Not." First published in 1859, the book aimed to improve the standards of nursing care and served as a basic instruction manual for student nurses.
However, her legacy extended beyond nursing into healthcare management, epidemiology, and public health. Nightingale’s work and philosophies have not only stood the test of time, but her teachings were instrumental in guiding policymakers and healthcare professionals during the COVID-19 pandemic. Here are some examples:
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For drug developers, FDA approval is a long and complex journey. Two of the most important milestones on this path are the Investigational New Drug (IND) application and the New Drug Application (NDA). While both are critical submissions, they serve very different purposes.
In August 2023, the U.S. Food and Drug Administration (FDA) announced the launch of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program. This initiative is designed to help sponsors of certain accelerated development products better align their CMC strategies with the FDA early in the development process.
In recent years, cell and gene therapies (CGTs) have transformed from scientific breakthroughs into commercial realities. These advanced modalities are redefining how we approach rare, genetic, and otherwise untreatable diseases—offering patients options that were once unimaginable. Yet, while the science is groundbreaking, the CMC (Chemistry, Manufacturing, and Controls) pathway remains one of the most significant obstacles to timely regulatory approval.