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Updated Monday through Friday
- CDER Launches New Accelerating Rare disease Cures (ARC) Program
- 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
June 6, 2023
- Draft Guidance: E6(R3) GOOD CLINICAL PRACTICE (GCP)
June 5, 2023
- Final Guidance: Cover Letter Attachments for Controlled Correspondences and ANDA Submissions
- Final Guidance: Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals
- FDA Drug Shortages
- Cisplatin Injection (New - Currently in Shortage)
- Fluticasone Propionate Inhalational Powder (New - Discontinuation)
June 1, 2023
May 31, 2023
- Competitive Generic Therapy Approvals (updated)
- FDA Drug Shortages
- Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Carboplatin Injection (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Cytarabine 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)
- Dextrose 50% 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)
- Fludarabine Phosphate 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 Sodium Succinate Injection (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Viscous) Oral Topical Solution (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)
- Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Methotrexate Injection (Updated - Currently in Shortage)
- Metronidazole Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Potassium Acetate Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Rifampin Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Acetate Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sodium Chloride 14.6% Injection (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sodium Phosphates Injection (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
- Sufentanil Citrate Injection (Updated - Currently in Shortage)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
May 30, 2023
- Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss
- Drug Trials Snapshot: NEXVIAZYME
- Drugs@FDA Data Files (updated)
May 26, 2023
May 25, 2023
- Guidance Snapshot Pilot (Updated)
- Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products (updated)
- Final Guidance: Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products (Updated)
- La FDA actualiza las advertencias para mejorar el uso seguro de los estimulantes recetados utilizados para tratar el TDAH y otras afecciones
- FDA Drug Shortages
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
May 24, 2023
- Guidance Snapshot Pilot (Updated)
- Draft Guidance: Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information
- Final Guidance: Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
- FDA Drug Shortages
- 0.9% Sodium Chloride Irrigation (Updated - Currently in Shortage)
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- IV Fat Emulsion (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Parathyroid Hormone (Natpara) Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
May 23, 2023
May 22, 2023
- Upcoming Product-Specific Guidances for Generic Drug Product Development (Updated)
- CDER Alert: G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging
- FDA Drug Shortages
- Carboplatin Injection (Updated - Currently in Shortage)
- Ibrutinib Tablets (New - Discontinuation)
May 19, 2023
- FDA approves treatment for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma
- FDA Drug Shortages
- Doxercalciferol Capsules (New - Discontinuation)
- Voriconazole Injection (New - Discontinuation)
May 18, 2023
- Drug Trials Snapshots: RYLAZE
- FDA Drug Shortages
- Estramustine Phosphate Sodium Capsules (New - Discontinuation)
- Lidocaine Hydrochloride (Viscous) Oral Topical Solution (New - Currently in Shortage)
- Upcoming Product-Specific Guidances for Generic Drug Product Development (Updated)
- FDA approves first oral treatment for moderately to severely active Crohn’s disease
May 17, 2023
- FDA Drug Shortages
- 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)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Fludarabine Phosphate Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Isoniazid Tablets (New - 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)
- Methotrexate Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Oxytocin Injection (Updated - Currently in Shortage)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Drug Trials Snapshots: SCEMBLIX
- Drug Trials Snapshots: REZUROCK
- Draft Guidance: Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act
- Draft Guidance: Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations
- CDER Statement: FDA issues two draft guidances for industry to support the approval of pediatric drug products
May 16, 2023
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages
- Bumetanide 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)
- Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Enalaprilat Injection (Updated - Currently in Shortage)Back to Top
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Lorazepam Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Sterile Water for Injection (Updated - Currently in Shortage)
- Valproate Sodium Injection (Updated - Currently in Shortage)
May 15, 2023
- Competitive Generic Therapy Approvals (Updated)
- Drug Trials Snapshots: VOXZOGO
- FDA Drug Shortages
- 0.9% Sodium Chloride Irrigation (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)
- Carboplatin Injection (Updated - Currently in Shortage)
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Conjugated Estrogens/Bazedoxifene (DUAVEE) Tablet, Film Coated (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% 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)
- Mannitol Injection (Updated - Currently in Shortage)
- Methotrexate Injection (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Midazolam Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
- Pentostatin Injection (Updated - Resolved)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Sodium Acetate Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection (Updated - Currently in Shortage)
- Sodium Chloride 14.6% Injection (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)
- Sterile Water for Irrigation (Updated - Currently in Shortage)
May 12, 2023
- FDA Drug Shortages
- Difluprednate Ophthalmic Emulsion (Updated - Currently in Shortage)
- Orange Book
May 11, 2023
- CDER Statement: FDA requires updates to clarify labeling of prescription stimulants used to treat ADHD and other conditions
- FDA Drug Safety Communication: FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions
- FDA Drug Shortages
- Paclitaxel Injection (protein-bound particles) (New - Resolved)
- Public Notification: V=GRA GOLD 500mg contains hidden drug ingredient
- SBIA Webinar - Overview: Clinical Pharmacology Considerations for Food Effect Studies
May 10, 2023
- FDA Drug Shortages
- Voriconazole Tablets (New - Discontinuation)
May 9, 2023
- Drugs@FDA Data Files (updated)
- Drug Trials Snapshot: RYBREVANT
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Oxycodone Hydrochloride Tablets (New - Discontinuation)
May 8, 2023
- FDA Drug Shortages
- Amoxapine Tablets (Updated - Currently in Shortage)
- Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Carboplatin Injection (Updated - Currently in Shortage)
- Clonazepam Tablets (Updated - Currently in Shortage)
- Fludarabine Phosphate Injection (New - Currently in Shortage)
- Fludarabine Phosphate Injection (Updated - Currently in Shortage)
- Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Isoniazid Injection (New - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Methotrexate Injection (Updated - Currently in Shortage)
- Neomycin Sulfate Tablets (Updated - Currently in Shortage)
- Final Guidance: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other HighRisk Drug Components for Diethylene Glycol and Ethylene Glycol
- Public Notifications
May 5, 2023
- FDA 更新了所有阿片類止痛藥的處方信息,以提供額外的安全使用指南
- Public Notifications:
- Phentamene XT contains hidden drug ingredient
- Honey Girl contains hidden drug ingredient
- Infinity 10K contains hidden drug ingredients
- Infinity contains hidden drug ingredient
- Mega 9K 800000 contains hidden drug ingredients
- Meta Forte contains hidden drug ingredients
- Natural MiracleZEN GOLD 60000 contains hidden drug ingredients
- XXX Zone 40K contains hidden drug ingredients
- MEGA 7G 700000 contains hidden drug ingredients
- Mr. Strong Guy Honey For Him contains hidden drug ingredient
- Platinum 69000 Rhino 69 contains hidden drug ingredient
- Power Plus Desire contains hidden drug ingredient
- Rhino 7S Type F3 7000 contains hidden drug ingredients
May 4, 2023
- FDA Drug Shortages
- Dulaglutide (Trulicity) Injection (Updated - Currently in Shortage)
- Semaglutide (WEGOVY®) Injection (Updated - Currently in Shortage)
- Zoledronic Acid Injection (New - Discontinuation)
- Public Notifications
May 3, 2023
- Competitive Generic Therapy Approvals (updated)
- Q9(R1) Quality Risk Management (updated)
May 2, 2023
- Drugs@FDA Data Files (updated)
- Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (updated)
- Health Communications Specialist Careers at CDER
- Writer/Editor Careers at CDER
- Technical Information Specialist Careers at CDER
- Business Informatics Specialist Careers at CDER
- Data Scientist Careers at CDER
- General Health Scientist Careers at CDER
- Health Science Policy Analyst Careers at CDER
- Pharmaceutical Scientist Careers at CDER
- Pharmacokineticist Careers at CDER
- Social Science Analyst Careers at CDER
- Biologist Careers at CDER
- Engineering Careers at CDER
- Clinical Analyst Careers at CDER
- Draft Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
- FDA Drug Shortages
- Remifentanil Injection (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)