Tag Archives: fast track approval

Part 4. On-site/Distant Inspection and Advisory Meetings   Table of contents 1. Drug GMP Inspection. 1.1.On-site Inspection. 1.2. Distant Inspection. 2 CDE Advisory Meetings and Communications. 2.1. Overview. 2.2. CDE Advisory Meetings. 2.3. Fast-track Review Meetings. 2.4. Technical Issue Communications. Drug review and approval challenges in 2020 included overcoming difficulties in completing facility inspection, conducting…

Part 3. Administrative Approval and Fast Track Review Pathways   Table of contents Administrative approval. Fast track review pathways. 2.1. Specialized pathway. 2.2. Breakthrough therapy. 2.3. Conditional approval. 2.4. Priority Review. In 2020 CDE approved: 1,435 Investigational New Drug (IND) applications, 208 New Drug Applications (NDAs), 918 Abbreviated New Drug Applications (ANDAs). This includes 59…