May 25, 2022

• FDA Drug Shortages
  • Iodixanol (Visipaque) Injection (Updated - Currently in Shortage)
  • Iohexol (Omnipaque) Injection (Updated - Currently in Shortage)
• Final Guidance for Industry: Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide

May 24, 2022

• Draft Guidance for Industry: Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Diflunisal Tablets (Updated - Currently in Shortage)
  • Fluvoxamine ER Capsules (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (New - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)

May 23, 2022

• Impact Story: Effects of Realistic In Vitro Test Factors on the Aerosol Properties of Metered-Dose Inhalers

May 20, 2022

• FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia
• FDA Drug Shortages
  • Bumetanide Injection (Updated - Currently in Shortage)
  • Cladribine Injection (New - Discontinuation)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Iodixanol (Visipaque) Injection (Updated - Currently in Shortage)
  • Iohexol (Omnipaque) Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)

May 19, 2022

• Drugs@FDA Data Files (updated)
• Upcoming Product-Specific Guidances for Complex Generic Drug Product Development (updated)
• Draft Guidance for Industry: Risk Management Plans to Mitigate the Potential for Drug Shortages
• FDA Drug Shortages
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Fluvoxamine ER Capsules (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
• Patent Certifications and Suitability Petitions (updated)

May 18, 2022

• FDA Drug Shortages
  • Nedocromil Sodium Ophthalmic Solution (New - Discontinuation)
  • Umbrasilib Tosylate Tablets (New - Discontinuation)
• Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (final guidance)

May 17, 2022

• Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 (final guidance)
• Competitive Generic Therapy Approvals (updated)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Daptomycin Injection (New - Discontinuation)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)

May 16, 2022

• FDA Drug Shortages
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lutetium Lu 177 Dotatate (LUTATHERA) Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Potassium Acetate Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• Final Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision

May 13, 2022

• Orange Book
  • Orange Book Current Cumulative Supplement (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)
• FDA Drug Shortages (New)
• 5/9/2022
  • Iodixanol (Visipaque) Injection (Currently in Shortage)
  • Iohexol (Omnipaque) Injection (Currently in Shortage)
  • Methocarbamol Injection (Discontinuation)
  • Risedronate Sodium Tablets (Discontinuation)
• FDA Drug Shortages (Updated)
• 5/12/2022
  • Methylprednisolone Acetate Injection (Currently in Shortage)
  • Potassium Acetate Injection (Currently in Shortage)
  • Rifampin Injection (Currently in Shortage)
  • Sodium Acetate Injection (Currently in Shortage)
  • Sodium Phosphates Injection (Currently in Shortage)
• 5/10/2022
  • Atropine Sulfate Injection (Currently in Shortage)
  • Bacteriostatic 0.9% Sodium Chloride Injection (Currently in Shortage)
  • Bacteriostatic Water for Injection (Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Currently in Shortage)
  • Dexmedetomidine Injection (Currently in Shortage)
  • Dextrose 50% Injection (Currently in Shortage)
  • Diltiazem Hydrochloride Injection (Currently in Shortage)
  • Disopyramide Phosphate (Norpace) Capsules (Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Currently in Shortage)
  • Dopamine Hydrochloride Injection (Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
  • Furosemide Injection (Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Currently in Shortage)
  • Ibutilide Fumarate Injection (Currently in Shortage)
  • Lorazepam Injection (Currently in Shortage)
  • Methylprednisolone Acetate Injection (Currently in Shortage)
  • Midazolam Injection (Currently in Shortage)
  • Morphine Sulfate Injection (Currently in Shortage)
  • Pantoprazole Sodium for Injection (Currently in Shortage)
  • Pentostatin Injection (Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Currently in Shortage)
  • Propofol Injectable Emulsion (Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Currently in Shortage)
  • Sodium Bicarbonate Injection (Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Currently in Shortage)
  • Sterile Water for Injection (Currently in Shortage)
  • Sulfasalazine Tablets (Currently in Shortage)
• 5/9/2022
  • Potassium Chloride Concentrate Injection (Currently in Shortage)

May 12, 2022

• FDA Approves Oral Form for the treatment of adults with amyotrophic lateral sclerosis (ALS)

May 11, 2022

• From Our Perspective: FDA’s Role in Helping a Critical Medical Isotope Meet Sufficient Supply in the US for First Time | FDA

May 10, 2022

• CDER Statement: CDER Launches New Accelerating Rare disease Cures (ARC) Program
• Drugs@FDA Data Files (updated)
• Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)

May 9, 2022

• FDA & American College of Rheumatology (ACR) Virtual Summit
• Draft Guidance for Industry: Benefit-Risk Considerations for Product Quality Assessments

May 6, 2022

• Drugs@FDA Data Files (updated)
• Competitive Generic Therapy Approvals (updated)

May 5, 2022

• FDA Drug Shortages
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Levoleucovorin Injection (New - Discontinuation)
• Spotlight on CDER Science: A Real-World Case Study of Levothyroxine Use Addresses Institutional Concerns About Generic Product Interchangeability

May 4, 2022

• FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer
• Draft Guidance for Industry: Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
• CDER Conversation: FDA Updates on Paxlovid for Health Care Providers (new)
• FDA Drug Shortages
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Calcium Gluconate Injection (Updated - Currently in Shortage)
  • Cytarabine Injection (Updated - Currently in Shortage)
  • Dacarbazine Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Furosemide Injection (Updated - Currently in Shortage)
  • Gentamicin Sulfate Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Lipid Injection (Updated - Currently in Shortage)
  • Mannitol Injection (Updated - Currently in Shortage)
  • Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Rifampin Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Sufentanil Citrate Injection (New - Currently in Shortage)
  • Sufentanil Citrate Injection (Updated - Currently in Shortage)

May 3, 2022

• FDA Drug Shortages
  • Dexmedetomidine Injection (Updated - Currently in Shortage)

May 2, 2022

• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Fluorescein Injection (New - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Tacrolimus Capsules (Updated - Resolved)
• Foreign language translations of FDA works to protect consumers from potentially harmful OTC skin lightening products
  • Hindi (हिन्दी) - शीर्षक: FDA उपभोक्ताओं को संभावित रूप से हानिकारक OTC स्किन लाइटनिंग उत्पादों से बचाने के लिए काम करता है
  • Korean (한국어) - 제목: FDA는 잠재적으로 유해한 OTC 피부 미백 제품으로부터 소비자를 보호하기 위해 노력합니다
  • Simplified Chinese (中文) - 标题：FDA 致力保护消费者免受潜在有害的非处方美白产品的危害
  • Somali (somaliyeed) - Ciwaanka: FDA waxay ka shaqeysaa inay ka ilaaliso macaamiisha badeecada iftiiminta maqaarka ee OTC ee waxyeelada leh
  • Spanish (Español) - Título: La FDA se esfuerza por proteger a los consumidores de productos de venta sin receta para aclarar la piel que son potencialmente dañino
  • Tagalog (Tagalog) - Pamagat: Nagtatrabaho ang FDA para protektahan ang mga mamimili mula sa potensyal na mapanganib na OTC na mga produkto sa pagpapaputi ng balat
  • Vietnamese (Tiếng Việt) - Tiêu đề: FDA hành động nhằm bảo vệ người tiêu dùng khỏi các sản phẩm làm sáng da không kê đơn có khả năng gây hại

April 29, 2022

• Guidances for Industry
  • FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
  • E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility
  • E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility
  • Electronic Submission of IND Safety Reports Technical Conformance Guide: Guidance for Industry
• FDA Drug Shortages
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Ibutilide Fumarate Injection (New - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
  • Technetium Tc 99m Sulfur Colloid Injection (Updated - Resolved)

April 28, 2022

• Draft Guidance for Industry: Crohn’s Disease: Developing Drugs for Treatment
• Draft Guidance for Industry: Ulcerative Colitis: Developing Drugs for Treatment

April 27, 2022

• CDER Conversations: Disclosing Information About Drugs and Fostering CDER’s Transparency Efforts
• FDA Drug Shortages
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
  • Lipid Injection (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
• Final Guidance for Industry: Providing Submissions in Electronic Format — Postmarketing Safety Reports

April 26, 2022

• FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy
• Regulatory Education for Industry (REdI) Annual Conference 2022
• Drugs@FDA Data Files (updated)

April 25, 2022

• Public Notifications:
  • Kingdom Honey Royal Honey VIP contains hidden drug ingredient
  • Cougar Secret Honey VIP contains hidden drug ingredient
  • Medcare Golden Royal Honey contains hidden drug ingredient
  • HoneyGizer™ contains hidden drug ingredient
  • ETUMAX VIP Royal Honey for Him contains hidden drug ingredients
  • Erkexin contains hidden drug ingredient
  • Royal Honey VIP contains hidden drug ingredient
  • Secret Miracle Honey (For Men) contains hidden drug ingredient
  • Secret Miracle Honey (For Women) contains hidden drug ingredient
  • Vital Honey contains hidden drug ingredient
  • UPDATED: Helmi’s Honey VIP contains hidden drug ingredient
  • UPDATED: X Rated Honey For Men contains hidden drug ingredient