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 21, 2023

• Draft Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
• Draft Guidance: Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
• FDA issues guidance on using remote oversight tools to help approve drugs

September 20, 2023

• Final Guidance: Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies
• FDA Drug Shortages
  • LISDEXAMFETAMINE DIMESYLATE CAPSULE (Updated - Currently in Shortage)
  • LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE (Updated - Currently in Shortage)

September 19, 2023

• Competitive Generic Therapy Approvals (updated)
• Drugs@FDA Data Files (Updated)
• Drug Trials Snapshots: LYBALVI
• Drug Trials Snapshots: ADBRY
• Drug Trials Snapshots: ELUCIREM
• FDA Drug Shortages
  • I.V. Fat Emulsion (Updated - Currently in Shortage)

September 18, 2023

• CDER Alert: FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules
• Draft Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
• Draft Guidance: Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
• FDA issues draft guidance regarding confirmatory evidence of clinical trials
• FDA Drug Shortages
  • Cisplatin Injection (Updated - Currently in Shortage)
  • EPINEPHRINE SOLUTION (New - Discontinuation)
  • Ketamine Hydrochloride Injection (Updated - Currently in Shortage)

September 15, 2023

• Draft Guidance: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1)
• Draft Guidance: Labeling for Biosimilar and Interchangeable Biosimilar Products

September 14, 2023

• FDA approves new and updated indications for temozolomide under Project Renewal
• FDA clarifies results of recent advisory committee meeting on oral phenylephrine 
• FDA Drug Shortages
  • Ibutilide Fumarate Injection (Updated - Resolved)
  • Imipramine Hydrochloride Injection (New - Discontinuation)
  • Itraconazole Capsules (New - Discontinuation)
    Vinblastine Sulfate Injection (New - Currently in Shortage)
• Drug Trials Snapshot: LIVTENCITY
• Final Guidance: Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry

September 13, 2023

• FDA Drug Shortages
  • Chlorothiazide Oral Suspension (Updated - Resolved)
  • Cisplatin Injection (Updated - Currently in Shortage)

September 12, 2023

• Drugs@FDA Data Files (Updated)
• Drug Trials Snapshots: WELIREG
• Drug Trials Snapshots: TIVDAK
• FDA Drug Shortages
  • Belatacept Lyophilized Powder for Injection (Updated - Resolved)
  • Lidocaine Hydrochloride (Viscous) Oral Topical Solution (New - Currently in Shortage)
  • Semaglutide (WEGOVY®) Injection (Updated - Currently in Shortage)
• Symposium: Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing

September 11, 2023

• Drug Trials Snapshot: OPDUALAG
• FDA Drug Shortages
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Cisatracurium Besylate Injection (New - Discontinuation)
  • Clindamycin Phosphate Injection (Updated - Currently in Shortage)
  • Desvenlafaxine Succinate Extended Release Tablets (New - Discontinuation)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Furosemide Injection (Updated - Currently in Shortage)
  • Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydrocortisone Sodium Succinate Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Isoniazid Tablets (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Methotrexate Injection (Updated - Currently in Shortage)
  • Methotrexate Tablets (Updated - Currently in Shortage)
  • Metronidazole Injection (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Penicillin G Benzathine Injectable Suspension (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Sodium Phosphates Injection (Updated - Currently in Shortage)
  • Somatropin Injection (Currently in Shortage)
  • Sterile Water for Injection (Updated - Currently in Shortage)
  • Streptozocin (Zanosar) Sterile Powder (Updated - Currently in Shortage)
  • Sucralfate Tablets (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)

September 8, 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)
• Draft Guidance: Clinical Pharmacology Considerations for Peptide Drug Products
• Final Guidance: Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products
• Lotronex (alosetron hydrochloride) Information (updated)

September 7, 2023

• Virtual Conference: BsUFA III Regulatory Science Pilot Program
• 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)