This blog features considerations and recommendations for sponsors exploring a 505(b)(2) pathway to drug approval. It was co-written by the Camargo team and the experts at Worldwide Clinical Trials, based on their joint on-demand webinar – 505(b)(2) Planning: Regulatory and Study Conduct Best Practices. In
Clinical Studies, Phases I-IV Articles and Insights
With drug discovery completed and your lead asset identified, it’s time to initiate IND-enabling activities, moving one step closer to clinical deployment. According to Tufts’ Center for the Study of Drug Development, less than 10% of nonclinical lead assets move into the clinic. The design,
Yesterday, FDA released draft guidance on the use of the Inactive Ingredient Database (IID) in drug development. The guidance is one step FDA is taking to address feedback from the generics industry that IID enhancements are needed to help sponsors make the right formulation decisions. What is the IID?