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- 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 8, 2023
- Orange Book
- Draft Guidance: Clinical Pharmacology Considerations for Peptide Drug Products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- Draft Guidance: Post-Warning Letter Meetings Under GDUFA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)
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
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
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
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)