What's New Related to Drugs

September 18, 2017

• Guidance for Industry: International Council for Harmonization - Quality
  • • Q4B: Annex I: Residue on Ignition/Sulphated Ash General Chapter  (PDF - 58KB)
    • Q4B: Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (PDF - 69KB)
    • Q4B: Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter  (PDF - 993KB)
    • Q4B: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter (PDF - 69KB)
    • Q4B: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter (PDF - 69KB)
    • Q4B: Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter (PDF - 57KB)
    • Q4B: Annex 5: Disintegration Test General Chapter (PDF - 69KB)
    • Q4B: Annex 8: Sterility Test General Chapter (PDF - 68KB)
    • Q4B: Annex 9: Tablet Friability General Chapter (PDF - 68KB)
    • Q4B: Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (PDF - 57KB)
  • ~Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• National Drug Code Directory (updated)
• Opportunities to Engage with the FDA About Qualification During Biomarker Development (PDF - 1.06MB)
• The Biomarker Qualification Process: A Roadmap for Requestors (PDF - 719KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

September 15, 2017

• FDA D.I.S.C.O.: A new treatment for acute myelogenous leukemia - Podcast
• FDA D.I.S.C.O.: A new treatment for acute myelogenous leukemia - Transcript
• The Biomarker Qualification Process: A Roadmap for Requesters – Podcast
• The Biomarker Qualification Process: A Roadmap for Requesters – Transcript
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Potassium Chloride Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

September 14, 2017

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA approves Aliqopa (copanlisib), a new treatment for adults with relapsed follicular lymphoma
• FDA approves Mvasi (bevacizumab-awwb), a biosimilar to the cancer drug Avastin, for certain colorectal, lung, brain, kidney and cervical cancers
• FDA Drug Safety Podcast: FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs
• FDA Drug Shortages
  • Sodium Phosphate Injection (Updated - Currently in Shortage)
• Manual of Policies and Procedures (MAPP) 5015.7 Rev. 1 Environmental Assessments and Claims of Categorical Exclusion (PDF - 87KB)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)