November 18, 2021

• 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)
  • Cefoxitin for Injection (Updated - Resolved)
  • Cefoxitin for Injection (Updated - Resolved)
  • Chlordiazepoxide Hydrochloride Capsules (New - Currently in Shortage)
  • Chlordiazepoxide Hydrochloride Capsules (Updated - Currently in Shortage)
  • Cytarabine Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (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)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Mannitol Injection (Updated - Currently in Shortage)
  • Midazolam Injection (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)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products

November 17, 2021

• 美国食品药品监督管理局警告含酒精洗手液进入眼睛可能会导致严重伤害 (Chinese language version of "FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury")
• Ongoing | Cancer Accelerated Approvals (updated)
• FDA Drug Shortages
  • Nefazodone Hydrochloride Tablets (Updated - Currently in Shortage)

November 16, 2021

• Competitive Generic Therapy Approvals (updated)
• Drugs@FDA Data Files (updated)
• Patent Certifications and Suitability Petitions (updated)
• FDA Drug Shortages
  • Clobetasol Propionate Topical Foam (New - Discontinuation)
  • Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection (Updated - Currently in Shortage)
• SterRx, LLC Issues Voluntary Nationwide Recall of Certain SterRx Products

November 15, 2021

• FDA Drug Shortages
  • Methohexital Sodium (Brevital) Injection (Updated - Resolved)
• Model-Informed Drug Development Pilot Program (updated)

November 12, 2021

• FDA Drug Shortages
  • Atropine Sulfate 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)

November 10, 2021

• FDA Drug Shortages
  • Famotidine Injection (Updated - Resolved)
  • Famotidine Tablets (Updated - Resolved)

November 9, 2021

• Comunicado sobre la seguridad de los medicamentos de la FDA: La FDA advierte que el contacto del desinfectante de manos a base de alcohol con los ojos puede causar lesiones graves Enjuagar inmediatamente los ojos con abundante agua corriente si esto ocurre
• Drugs@FDA Data Files (updated)
• Impact Story: Exploiting Real-World Data to Optimize the Use of Antibiotics
• FDA Adverse Event Reporting System (FAERS) Electronic Submissions (updated)

November 8, 2021

• FDA Drug Shortages
  • Amoxapine Tablets (Updated - Currently in Shortage)
  • Azacitidine for Injection (Updated - Currently in Shortage)
  • Famotidine Tablets (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Leuprolide Acetate Injection (Updated - Currently in Shortage)
  • Loxapine Capsules (Updated - Currently in Shortage)
  • Nizatidine Capsules (Updated - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
• Public Meeting on Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA) (updated)

November 5, 2021

• FDA Drug Shortages
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
  • Ethambutol Hydrochloride Tablets (New - Discontinuation)
  • Furosemide Injection (New - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Methimazole Tablets (New - Discontinuation)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)

November 4, 2021

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Calcium Gluconate Injection (Updated - Currently in Shortage)
  • Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Furosemide 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)
  • Mannitol Injection (Updated - Currently in Shortage)
  • Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Acetate Injection (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)

November 3, 2021

• CDER’s Work to Meet User Fee Goals During the Pandemic (updated)
• Modernization of the FDA CDER Export Certificate Program
• FDA Notification Regarding Isoxsuprine Hydrochloride Drug Products (updated)

November 2, 2021

• Drugs@FDA Data Files (updated)
• FDA Drug Safety Communication: FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
• Patent Certifications and Suitability Petitions (updated)
• Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs (updated)
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bumetanide Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Cytarabine 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)
  • Efavirenz Tablets (New - Discontinuation)
  • Epinephrine Injection, 0.1 mg/mL (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)
  • 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)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Misoprostol Tablets (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (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)
  • Potassium Chloride Concentrate Injection (New - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (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)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)

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)