CDER New March 31, 2015

What's New on the FDA Drugs Site

March 30, 2015

• Critical Path Innovation Meetings Guidance for Industry (PDF - 69KB)
• Development and Submission of Near Infrared Analytical Procedures Guidance for Industry (PDF - 176KB)
• FDA Drug Safety Communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol)
• FDA Drug Safety Podcast: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir Harvoni or Sovaldi in combination with another Direct Acting Antiviral drug
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)