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 sponsors developing new therapies, one of the most critical milestones on the regulatory pathway is preparing and submitting a New Drug Application (NDA). While biologics require a Biologics License Application (BLA), small-molecule drugs follow the NDA process.
The BLA is more than just an administrative step. It is the culmination of years of research, development, manufacturing, and clinical testing, and it represents the sponsor’s formal request that the FDA approve a biologic for commercial distribution in the United States.
Whether you’re submitting to the FDA, EMA, or another authority, the CSR must tell a clear, compliant, and credible story of your trial. GLOBAL's Medical Writing team shares tips and tricks to get it right.
