January 4, 2023

• Final Guidance: Format and Content of a REMS Document Guidance for Industry

January 3, 2023

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Abacavir Sulfate (Ziagen) Tablets (New - Discontinuation)
  • Abacavir Sulfate; Lamivudine (Epzicom) Tablets (New - Discontinuation)
  • Abacavir Sulfate; Lamivudine; Zidovudine (Trizivir) Tablets (New - Discontinuation)
  • Dolutegravir Sodium (Tivicay) Tablets (New - Discontinuation)
  • Fosamprenavir Calcium (Lexiva) Oral Solution (New - Discontinuation)
  • Fosamprenavir Calcium (Lexiva) Tablets (New - Discontinuation)
  • Glyburide (GLYNASE) Tablets (New - Discontinuation)
  • Indigotindisulfonate Sodium Injection (Updated - Currently in Shortage)
  • Maraviroc (Selzentry) Tablets (New - Discontinuation)
• Upcoming Webinar: Overview: Clinical Pharmacology Considerations for Neonatal Studies

December 28, 2022

• FDA Drug Shortages
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • IV Fat Emulsion (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)

December 27, 2022

• October 28, 2022 Meeting of the Oncologic Drugs Advisory Committee - Transcript (New)
• ANDA Assessment Program – GDUFA III Performance Goals and Program Enhancements (Update)
  • GDUFA III Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings: Video Recording (New)
• Impact story: Prescription drug promotion in online character space limited (CSL) communications (New)
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Iomeprol Injection (Updated - Resolved)

December 23, 2022

• Drug Shortages
  • New
    • Azithromycin for Suspension (Discontinuation) 12/22/2022
    • Azithromycin Tablets (Discontinuation) 12/22/2022
    • Ranolazine Extended-Release Tablets (Discontinuation) 12/22/2022
    • Difluprednate Ophthalmic Emulsion (Currently in Shortage) 12/21/2022
    • Chlorothiazide Oral Suspension (Currently in Shortage) 12/20/2022
    • Budesonide Inhalational Suspension (Discontinuation) 12/19/2022
  • Update
    • Etomidate Injection (Currently in Shortage) 12/22/2022
    • Ibutilide Fumarate Injection (Currently in Shortage) 12/22/2022
    • Etomidate Injection (Currently in Shortage) 12/21/2022
    • Ketamine Injection (Currently in Shortage) 12/21/2022
    • Leucovorin Calcium Lyophilized Powder for Injection (Currently in Shortage) 12/21/2022
    • Remifentanil Injection (Currently in Shortage) 12/21/2022
    • Rifampin Injection (Currently in Shortage) 12/21/2022
    • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Currently in Shortage) 12/19/2022
    • Azacitidine for Injection (Currently in Shortage) 12/19/2022

December 21, 2022

• Draft Guidance: Controlled Correspondence Related to Generic Drug Development
• Draft Guidance: M11 Clinical Electronic Structured Harmonised Protocol
• Draft Guidance: M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol
• Draft Guidance: M11 Template: Clinical Electronic Structured Harmonised Protocol

December 20, 2022

• Drugs@FDA Data Files (updated)

December 19, 2022

• Competitive Generic Therapy Approvals (updated)
• Oncology Burst: FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer

December 16, 2022

• Podcast: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)
• Notable Approval: FDA approves imaging drug to help identify lung cancer lesions
• FDA Drug Shortages
  • Fluvoxamine ER Capsules (Updated - Resolved)
• Spotlight on CDER: Assessing the Respiratory Effects of Approved Opioid Products When Co-administered with Commonly Prescribed Drugs

December 15, 2022

• Generic Drugs Program Monthly and Quarterly Activities Report
• FDA Drug Shortages
  • Dulaglutide (Trulicity) Injection (New - Currently in Shortage)
  • Tirzepatide Injection (New - Currently in Shortage)
• Guidance: Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (updated)

December 14, 2022

• Guidance: Pulmonary Tuberculosis: Developing Drugs for Treatment (updated)
• Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry (updated)
• FDA Drug Shortages
  • Amoxapine Tablets (Updated - Currently in Shortage)

December 13, 2022

• Drugs@FDA Data Files (updated)
• List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (Updated)
• Drug Trial Snapshot: PEPAXTO
• FDA Drug Shortages
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (Updated - Resolved)
  • Fentanyl Citrate (Sublimaze) 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)
  • Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Midazolam Injection (Updated - Currently in Shortage)

December 12, 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)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Furosemide Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)

December 9, 2022

• FDA Drug Shortages
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Methylphenidate Hydrochloride Extended Release Tablets (New - Discontinuation) 
• 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)

December 8, 2022

• Draft Guidance: Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations

December 7, 2022

• Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry (updated)
• FDA Drug Shortages
  • Fluorescein Injection (Updated - Resolved)

December 6, 2022

• Drugs@FDA Data Files (updated)
• Compounding Outsourcing Facilities Annual Study

December 5, 2022

• Drug Safety Communication: Comunicado de la FDA sobre la seguridad de medicamentos, La FDA investiga el riesgo de hipocalcemia grave en pacientes de diálisis que reciben el medicamento para la osteoporosis Prolia (denosumab)
• Drug Safety Communication: 美国食品和药物管理局药物安全通讯 美国食品和药物管理局正在调查接受骨质疏松症药物 Prolia（狄诺塞麦）的透析患者患有严重低血钙症的风险
• Final Guidance: E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials