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

September 7, 2023

• Video Interviewing With CDER
• Frequently Asked Questions About Video Interviewing With CDER
• Submit Your CDER Video Interview

September 6, 2023

• Ongoing | Cancer Accelerated Approvals (updated)

September 5, 2023

• First Generic Drug Approvals (Updated)
• Drugs@FDA Data Files (Updated)

September 1, 2023

• Competitive Generic Therapy Approvals (Updated)
• Draft Guidance: Post-Warning Letter Meetings Under GDUFA
• Final Guidance: Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment

August 31, 2023

• Public Notification: Tapee Tea contains hidden drug ingredients
• CDER Quality Management Maturity (updated)

August 30, 2023

• Final Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
• Final Guidance: Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act
• CDER Statement: DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems
• Final Guidance: Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies

August 29, 2023

• Drugs@FDA Data Files (Updated)

August 25, 2023

• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
  • Bacteriostatic Water for Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Carboplatin Injection (Updated - Currently in Shortage)
  • Clindamycin Phosphate Injection (Updated - Currently in Shortage)
  • Cytarabine Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Dextrose 25% Injection (Updated - Currently in Shortage)
  • Dextrose 50% Injection (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride 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)
  • Etomidate 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)
  • Hydrocortisone Sodium Succinate Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Ibutilide Fumarate 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)
  • Somatropin Injection (Updated - Currently in Shortage)

August 25, 2023

• Final Guidance: Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies

August 24, 2023

• Drug Trials Snapshots: BESREMi
• Biosimilar Product Information (updated)
• FDA Drug Shortages
  • Piroxicam Capsules (New - Discontinuation)

August 23, 2023

• FDA Drug Shortages
  • Bumetanide Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Furosemide Injection (Updated - Currently in Shortage)
  • Iobenguane I-131 Injection, Solution (New - Discontinuation)
  • IV Fat Emulsion (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)

August 22, 2023

• FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination
• Drugs@FDA Data Files (Updated)
• FDA Drug Shortages
  • Albuterol Sulfate Inhalation Solution, 0.5% (Updated - Currently in Shortage)
  • Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Methotrexate Tablets (Updated - Currently in Shortage)
  • Oxybutynin Chloride Syrup (Updated - Currently in Shortage)
  • Quinapril and Hydrochlorothiazide Tablets (Updated - Currently in Shortage)
  • Quinapril Hydrochloride Tablets (Updated - Currently in Shortage)
• Public Notifications:
  • BIG GUYS Male Energy Supplement contains hidden drug ingredient
  • Mens Maximum Energy Supplement contains hidden drug ingredient
  • Round 2 contains hidden drug ingredient
  • Genergy contains hidden drug ingredient
  • WeFun contains hidden drug ingredient
  • X MAX Triple Shot Energy Honey contains hidden drug ingredient
• Drug Trials Snapshot: LUMAKRAS
• Compounding Quality Center of Excellence Annual Conference (updated)
• Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding (updated)

August 18, 2023

• Conference: Use of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic NASH Trials

August 17, 2023

• FDA approves first treatment for Fibrodysplasia Ossificans Progressiva
• Drug Trials Snapshot: KERENDIA
• FDA Drug Shortages
  • Ibuprofen and Famotidine Tablets (New - Discontinuation)

August 16, 2023

• Drug Trials Snapshot: SKYTROFA
• Drug Trials Snapshot: EXKIVITY

August 15, 2023

• Drugs@FDA Data Files (updated)

August 14, 2023

• FDA Drug Shortages
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium Injection (Updated - Currently in Shortage)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Oxytocin Injection (Updated - Resolved)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Somatropin Injection (Updated - Currently in Shortage)

August 11, 2023

• 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)

August 10, 2023

• Webinar: Understanding FDA Inspections and Data
• 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials
• FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma
• CDER Conversation: FDA works through ICH to support global drug development: creating harmonized technical standards through guidelines
• FDA Drug Shortages
  • Technetium TC-99M Mebrofenin Injection (Updated - Resolved)

August 9, 2023

• ClinicalTrials.gov – a Three-Part Series
• Medication Health Fraud (Updated)
• Medication Health Fraud for Specific Diseases and Conditions
• FDA Actions to Stop Medication Health Fraud
• Medication Health Fraud Questions and Answers
• Public Notification: Vegetal Vigra 200mg contains hidden drug ingredient
• FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions
• FDA Drug Shortages
  • Bumetanide Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Carboplatin Injection (Updated - Currently in Shortage)
  • Chloramphenicol Sodium Succinate Injection (Updated - Currently in Shortage)
  • Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Dacarbazine Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Etomidate Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Gentamicin Sulfate Injection (Updated - Currently in Shortage)
  • Glipizide XL Tablets (New - Discontinuation)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Leucovorin Calcium 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)
  • Methotrexate Injection (Updated - Currently in Shortage)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride 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 Phosphates Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)

August 8, 2023

• Drugs@FDA Data Files (updated)

August 7, 2023

• CDERLearn Training and Education (updated)