In 2018, the FDA’s Oncology Center of Excellence developed an Assessment Aid document to help facilitate review of New Drug Applications (NDAs)/Biologics License Applications (BLAs) (including supplements) submitted to the Center for Drug Evaluation and Research’s (CDER’s) Office of Oncology Diseases (OOD). Providing the Assessment Aid with your NDA/BLA is voluntary. As noted by the … Continued
In chemistry, manufacturing, and controls (CMC) regulatory writing, there is a difference in the level of detail required for New Drug Applications (NDAs) and Biologic License Application (BLAs) supporting different types of products. The expectations tend to diminish as time elapses and the regulatory authority becomes more familiar with a specific type of medicinal product. … Continued
Meet Rachel Bombara, Sr. Regulatory Operations Specialist at Certara. In this brief video Rachel shares how she manages tight deadlines and how she leverages technology to support her daily submission work.
The United Kingdom (UK) officially left the European Union (EU) on 31 January 2020. According to the withdrawal agreement, it is now officially a third country to the EU and no longer participates in EU decision making. The agreement established a transition period that ended on 31 December 2020.1 As a result, the Medicines and … Continued
