Updated Monday through Friday

• Drug Firm Annual Registration Status 
• Drug Firm Annual Registration Status Download File 
• National Drug Code Directory 
• NDC Unfinished Drugs Excluded Database File 
• NDC Database Excluded Packages and Products 
• Wholesale Distributor and Third-Party Logistics Providers Reporting

November 6, 2023

• SBIA Conference: Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources
• FDA Drug Shortages
  • Azacitidine Injection (Updated - Currently in Shortage)
  • Diazepam Gel (New - Currently in Shortage)
  • Flurazepam Hydrochloride Capsule (Updated - Currently in Shortage)
  • Methotrexate Sodium Injection (Updated - Currently in Shortage)

November 3, 2023

• FDA warns consumers of hidden drug ingredients in Dr. Ergin’s SugarMD Advanced Glucose Support
• Webinar: Implementing DSCSA: Stabilization Period and Expectations
• Final Guidance: Submitting Patient-Reported Outcome Data in Cancer Clinical Trials
• Final Guidance: Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory
• FDA Drug Shortages
  • Cromolyn Sodium Concentrate (New - Currently in Shortage)
  • Fluorescein Sodium Injection (New - Currently in Shortage)
  • Ofatumumab Injection (New - Discontinuation)

November 2, 2023

• FDA Drug Shortages
  • Amino Acid Injection (Updated - Currently in Shortage)
  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Updated - Currently in Shortage)
  • Azacitidine Injection (Updated - Currently in Shortage)
  • Cefixime Capsule (Updated - Currently in Shortage)
  • Chloroprocaine Hydrochloride Injection (Updated - Discontinuation)
  • Dexmedetomidine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dextrose Monohydrate Injection (Updated - Currently in Shortage)
  • Dextrose Monohydrate, Lidocaine Hydrochloride Anhydrous Injection (Updated - Currently in Shortage)
  • Difluprednate Emulsion (Updated - Currently in Shortage)
  • Erythromycin Ointment (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Furosemide Injection (Updated - Currently in Shortage)
  • I.V. Fat Emulsion (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride Injection (New - Currently in Shortage)
  • Lidocaine Hydrochloride Solution (Updated - Currently in Shortage)
  • Mannitol Injection (Updated - Currently in Shortage)
  • Methamphetamine Hydrochloride Tablet (Updated - Currently in Shortage)
  • Methotrexate Sodium Injection (Updated - Currently in Shortage)
  • Methyldopa Tablet, Film Coated (Currently in Shortage)
  • Methylphenidate Hydrochloride Tablet, Extended Release (Updated - Currently in Shortage)
  • Midazolam Hydrochloride Injection (Updated - Currently in Shortage)
  • Potassium Chloride Injection (Updated - Currently in Shortage)
  • Remifentanil Hydrochloride Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection (Updated - Currently in Shortage)
  • Somatropin Injection (Updated - Currently in Shortage)
  • Sterile Water Injection (Updated - Currently in Shortage)
  • Sulfasalazine Tablet (Updated - Currently in Shortage)
• INFORMED CONSENT TEMPLATE FOR INDIVIDUAL PATIENT EXPANDED ACCESS

November 1, 2023

• Public Meeting on Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement
• FDA’s 50 Years of Experience with Cannabis Research Helping to Support Tomorrow’s Cannabis Drug Development
• FDA approves pembrolizumab with chemotherapy for biliary tract cancer
• FDA Drug Shortages
  • Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Capecitabine Tablet (Updated - Currently in Shortage)
  • Carboplatin Injection (Updated - Currently in Shortage)
  • Cromolyn Sodium Oral Solution (New - Discontinuation)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Furosemide Injection (Updated - Currently in Shortage)
  • Ketamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection Updated - (Currently in Shortage)
  • Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Lisdexamfetamine Dimesylate Capsule (New - Currently in Shortage)
  • Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Triamcinolone Acetonide Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide Injection (Updated - Currently in Shortage)

October 31, 2023

• Drugs@FDA Data Files (Updated)

October 30, 2023

• Patent Certifications and Suitability Petitions (updated)
• Competitive Generic Therapy Approvals (updated)
• Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (updated)
• Upcoming Live CE Webinar: FDA Drug Topics: Advancing Transparency and Regulatory Science Activities on the Risk Evaluation and Mitigation Strategy (REMS) - November 28, 2023
• FDA approves toripalimab-tpzi for nasopharyngeal carcinoma
• FDA Drug Shortages
  • Multi-Vitamin Infusion (Adult and Pediatric) Injection (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) Injection (Updated - Discontinuation)

October 27, 2023

• FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection

October 26, 2023

• Drug Trials Snapshot: LYTGOBI
• FDA Drug Shortages
  • Carboplatin Injection (New - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Clofarabine Injection (New - Discontinuation)
  • Fulvestrant Solution (New - Discontinuation)
  • Vinblastine Sulfate Injection (Updated - Currently in Shortage)
• Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products

October 25, 2023

• Draft Guidance: Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
• Drug Trials Snapshot: LUNSUMIO
• Draft Guidance: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
• FDA Drug Shortages
  • Lutetium Lu-177 Vipivotide Tetraxetan Injection (Updated - Resolved)
  • Mesalamine Capsule, Delayed Release (New - Discontinuation)

October 24, 2023

• Drugs@FDA Data Files (Updated)
• Drug Trial Snapshots: ELAHERE
• FDA Drug Shortages
  • Carboplatin Injection (Updated - Currently in Shortage)
  • Dacarbazine Injection (New - Currently in Shortage)

October 23, 2023

• Draft Guidance: Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers

October 20, 2023

• FDA expands pediatric indication for entrectinib and approves new pellet formulation

October 19, 2023

• FDA Drug Shortages
  • Cisplatin Injection (Updated - Currently in Shortage)
• Drug Trial Snapshots: CYTALUX
• Public Notification: The Rock contains hidden drug ingredient

October 17, 2023

• FDA Drug Shortages
  • Colestipol Hydrochloride Granule (New - Discontinuation)
  • Technetium Tc-99m Sodium Pertechnetate Generator (New - Discontinuation)
• Toward Global IDMP Implementation: A Focus on Global Use Cases
• CDER soliciting comments regarding clinical trial innovation
• Drugs@FDA Data Files (Updated)
• Competitive Generic Therapy Approvals (updated)

October 16, 2023

• A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Workshop
• Draft Guidance: Diabetic Foot Infections: Developing Drugs for Treatment
• Final Guidance: Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
• FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer

October 13, 2023

• Event: FDA Clinical Investigator Training Course (CITC) 2023
• FDA Drug Shortages
  • Streptozocin Powder, For Solution (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)
• iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) (Updated)

October 12, 2023

• Drug Trials Snapshots: ENJAYMO
• Draft Guidance: Quality Considerations for Topical Ophthalmic Drug Products
• FDA Drug Shortages
  • Neomycin Sulfate Tablet (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Tirzepatide Injection (Updated - Currently in Shortage)

October 11, 2023

• FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation
• FDA Drug Shortages
  • Difluprednate Emulsion (Updated- Currently in Shortage)

October 10, 2023

• Drugs@FDA Data Files (Updated)
• FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders

October 6, 2023

• FDA Drug Shortages
  • Nitroglycerin Injectable (New - Currently in Shortage)