CDER New July 7, 2015

What's New on the FDA Drugs Site

July 6, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Safety Podcast: FDA evaluating the potential risks of using codeine cough-and-cold medicines in children
• National Drug Code Directory
• Patient-Focused Drug Development: Disease Area Meetings Planned for Fiscal Years 2013-2017(updated)
• Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
• Qualification of BiomarkerPlasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Draft Guidance for Industry (PDF - 40B)