CDER New February 8, 2018

February 7, 2018

• Considerations for applicants deciding when to submit elemental impurity data to FDA (PDF - 87 KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated) 
• eCTD Submission Types and Sub-Types (PDF - 630 KB)
• FDA Drug Safety Podcast: FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease
• Microbiology Data for Systemic Antibacterial Drugs —Development, Analysis, and Presentation: Guidance for Industry (PDF - 163KB)
• National Drug Code Directory (updated)
• Office of Drug Evaluation IV – Personnel (updated)
• Pediatric Exclusivity Statistics (updated)
• Table of Pharmacogenomic Biomarkers in Drug Labeling  (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)