Welcome to the CERES Regulatory Services blog! Here, you’ll find a wide range of articles and resources on Accelerated Approval Pathways and FDA Fast Track Designation, FDA Breakthrough Therapy Designation, FDA Priority Review Designation, FDA Approval Process, Regulatory Strategy for Therapeutics (Drugs, Biologics, Vaccines, Medical Devices, Cell and Gene Therapy and Advanced Tissue Products), Nonclinical Development, Clinical Development, FDA Meetings, Drug Development Pathways, Expedited Drug Approval, Innovative Therapies Development, NDA and BLA Submission Strategies, FDA Regulatory Guidance, FDA Accelerated and Expedited programs and Strategies of Interest to the Regulatory Scientist.