CDER New April 20, 2016

What's New on the FDA Drugs Site

 April 19, 2016

• Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry (PDF - 200KB)
• Drug Trials Snapshots: TALTZ
• Manual of Policies and Procedures (MAPP) 5015.6 Rev.1 Review of Grouped Product Quality Supplements (PDF - 92KB)
• Paragraph IV Patent Certifications (updated)
• FDA Drug Safety Communication (Spanish)  La FDA agrega advertencias acerca del riesgo de insuficiencia cardiaca a las etiquetas de los medicamentos para diabetes tipo 2 que contengan saxagliptina y alogliptina
• FDA Drug Shortages
  • Cefepime Injection (Updated - Currently in Shortage)