CDER New April 22, 2015

What's New on the FDA Drugs Site

April 21, 2015

• Public Notification: Extreme Diamond 3000 contains hidden drug ingredient
• DDI Webinar- Know Your Source - Protecting Patients from Unsafe Drugs - April 28, 2015
• Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Doxorubicin (Adriamycin) Injection   (Updated - Currently in Shortage)
  • Methylene Blue Injection (New - Currently in Shortage)
  • Nebivolol (BYSTOLIC) Tablets   (Updated - Currently in Shortage)
  • Trace Elements   (Updated - Currently in Shortage)
• Guidance for Industry:
  • Clinical Trial Endpoints for the Approval of Non- Small Cell Lung Cancer Drugs and Biologics Guidance for Industry (PDF - 343KB)
  • Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs Guidance for Industry (PDF - 252KB)
• National Drug Code Directory
• Paragraph IV Patent Certifications (updated)