CDER New June 25, 2015

What's New on the FDA Drugs Site

June 24, 2015

• Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products Guidance for Industry (PDF - 77KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Safety Communication: FDA reporting permanent skin color changes associated with use of Daytrana patch (methylphenidate transdermal system) for treating ADHD
• National Drug Code Directory
• Paragraph IV Patent Certifications (updated)
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)