CDER New December 21, 2016

What's New on the FDA Drugs Site

December 20, 2016

• Director's Corner Podcasts: Addressing the Opioid Epidemic—Dr. Woodcock discusses the FDA’s actions to implement the Opioid Action Plan, including important safety labeling changes.
• Drug Shortages: New technology platform for Industry to send drug shortage and supply notifications.
• Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
• Paragraph IV Patent Certifications (updated)