November 2, 2021

FDA Drug Safety Communication: FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury

November 1, 2021

• Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts (updated)
• Human Drug Exports
• Generic Drug Research Priorities & Projects
• Ongoing | Cancer Accelerated Approvals
• Integrated Assessment of Marketing Applications Virtual Workshop
• FDA approves asciminib for Philadelphia chromosome-positive chronic myeloid leukemia (new)
• Cancer Accelerated Approvals (new)
  • Ongoing | Cancer Accelerated Approvals
  • Verified Clinical Benefit | Cancer Accelerated Approvals
  • Withdrawn | Cancer Accelerated Approvals
• FDA Drug Shortages
  • Clobetasol Propionate Topical Solution, 0.05% (New - Discontinuation)

October 29, 2021

• Competitive Generic Therapy Approvals
• FDA Drug Shortages
  • Cefdinir Powder for Suspension (New - Discontinuation)
  • Lipid Injection (Updated - Currently in Shortage)
• Guidance for Industry:
  • Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry
  • Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide

October 28, 2021

• FDA Physician Communication Project: Testing with Professional Societies
• Nurse Pain Educator Pilot Program
• Integrated Clinical Decision Support System to Advance the Safe Use of Antibiotics
• Pragmatic Risk Score for Severe Hypoglycemic Events
• FDA Drug Shortages
  • Samarium SM 153 Lexidronam (Quadramet) Injection (New - Discontinuation)
• From Our Perspective: FDA Holds Workshop to Discuss the Safe Use of Benzodiazepines

October 27, 2021

• FDA Drug Shortages
  • Lipid Injection (New - Currently in Shortage)
• CDER Leadership Bios (updated)

October 26, 2021

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Lipid Injection (New - Currently in Shortage)
• CDERLearn Training and Education (updated)
• Clinical Investigator Training Course (CITC) Update - 12/07/2021 - 12/08/2021 (updated)

October 25, 2021

• FDA Drug Shortages
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Chlordiazepoxide Hydrochloride Capsules (Updated - Currently in Shortage)
  • Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Lipid (Smoflipid) Injectable Emulsion (New - Currently in Shortage)
  • Loxapine Capsules (Updated - Currently in Shortage)
  • Physostigmine Salicylate Injection (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Triamcinolone Acetonide Injectable Suspension (Updated - Currently in Shortage)

October 22, 2021

• Quarterly Inactive Ingredient Database (IID) Change Log (updated)

October 21, 2021

• CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19 (updated)
• Data Standards for Drug and Biological Product Submissions Containing Real-World Data Guidance for Industry
• Merck Issues Voluntary Nationwide Recall of CUBICIN (Daptomycin for Injection) 500 mg, Lot 934778, Due to Presence of Particulate Matter Identified as Glass Particles
• FDA Drug Shortages
  • Vitamin A Palmitate (Aquasol A) Injection (New - Currently in Shortage)

October 20, 2021

• Patent Certifications and Suitability Petitions (updated)
• FDA Drug Shortages
  • Dacarbazine Injection (New - Currently in Shortage)
  • Nafcillin Injection (New - Discontinuation)
• Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan (updated)
• Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Methocarbamol 500mg Bottles Due to Mislabeling With the Incorrect Strength

October 19, 2021

• Drugs@FDA Data Files (updated)

October 18, 2021

• FDA approves naloxone injection to counteract opioid overdoses
• Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (Updated)
• Generic Drug User Fee Amendments (updated)
• FDA Drug Shortages
  • Amino Acids (Updated - Currently in Shortage)
  • Pioglitazone/Metformin HCl (ACTOPLUS MET®) Tablets (New - Discontinuation)

October 15, 2021

• FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer
• FDA Drug Shortages
  • Busulfan Injection (New - Discontinuation)

October 14, 2021

• Competitive Generic Therapy Approvals
• Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity

October 13, 2021

• FDA approves pembrolizumab combination for the first-line treatment of cervical cancer
• Regulatory Policy Information
• FDA approves abemaciclib with endocrine therapy for early breast cancer 
• Q13 Continuous Manufacturing of Drug Substances and Drug Products
• Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency
• FDA Drug Shortages
  • Midazolam Injection (Updated - Currently in Shortage)
  • Metronidazole (Flagyl) Tablets (New - Discontinuation)

October 12, 2021

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bumetanide Injection (Updated - Currently in Shortage)
  • Ceftolozane and Tazobactam (Zerbaxa) Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (New - Currently in Shortage)
  • Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (Updated - Currently in Shortage)
  • Enalaprilat Injection (Updated - Currently in Shortage)
  • Famotidine Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Floxuridine for Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Montelukast Sodium Chewable Tablet (New - Discontinuation)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Valproate Sodium Injection (Updated - Currently in Shortage)

October 8, 2021

• CDER Conversation: Novel Excipient Review Pilot Program
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bumetanide Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Cefotaxime Sodium Injection (Updated - Currently in Shortage)
  • Cytarabine Injection (Updated - Currently in Shortage)
  • Daptomycin Injection (New - Discontinuation)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (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)
  • Hydrocortisone Tablets (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection (New - Currently in Shortage)
  • Leuprolide Acetate Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Lorazepam Injection (Updated - Currently in Shortage)
  • Mannitol Injection (Updated - Currently in Shortage)
  • Methyldopa Tablets (Updated - Discontinuation)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Misoprostol Tablets (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Potassium Acetate Injection (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• 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)
  • Appendix A: Product Name Index (updated)
  • Appendix B: Product Name Sorted by Applicant (updated)
  • Appendix C: Uniform Terms (updated)

October 7, 2021

• FDA recognizes Memorial Sloan-Kettering database of molecular tumor marker information
• FDA updates on hand sanitizers consumers should not use (updated)
• FDA Drug Shortages
  • Azacitidine for Injection (New - Currently in Shortage)
  • Cefotaxime Sodium Injection (Updated - Currently in Shortage)
  • Chlordiazepoxide Hydrochloride Capsules (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Loxapine Capsules (Updated - Currently in Shortage)
  • Nizatidine Capsules (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)

October 6, 2021

• CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19 (updated)
• FDA Drug Shortages
  • Digoxin Injection (Updated - Currently in Shortage)
  • Paclitaxel Injection (protein-bound particles) (Updated - Currently in Shortage)
• Guidance for Industry:
  • S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals
  • Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

October 5, 2021

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Paclitaxel Injection (protein-bound particles) (New - Currently in Shortage)

October 4, 2021

• FDA Drug Shortages
  • Timolol Maleate Ophthalmic Gel Forming Solution (Updated - Resolved)