The US Food and Drug Administration 505(b)(2) New Drug Application (NDA) pathway allows sponsors to use existing public data in lieu of conducting nonclinical and clinical studies, potentially offering significant drug development and marketing advantages. Nonclinical testing programs for 505(b)(2)...
Tag: Drug Development 7 results
In today’s fast-paced world of scientific discovery, cutting-edge technology is revolutionizing the way we approach complex biological problems. One such innovation is in silico modeling, a method that harnesses the power of computer simulations to model biological systems. But what...
Consulting
CMC Considerations for Pre-IND Meetings
The pre-IND meeting is an opportunity for highly productive interactions between sponsors and the FDA, allowing for discussion of key material attributes and development strategy plus requests for Agency review and advice on specific topics. In general, such meetings are...
The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval. With many steps in between, each as important as the next, multiple factors regarding development strategy...
Oncology & Hematology
Considerations for Operationalizing Pediatric Oncology Studies
Remarkable progress has been made in our understanding of the genomics of pediatric cancers, and these advancements have led to the recognition that products being studied for use in adult cancer indications may have health benefits for pediatric patients. By...