May 11, 2023

• 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
  • Fast-Act Rheuma Capsule contains hidden drug ingredients
  • New Fast-Act Rheumatism Capsule contains hidden drug ingredient
  • UA-Block contains hidden drug ingredient

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
  • Diamond Girl Lite contains hidden drug ingredient
  • Hard Steel 300K contains hidden drug ingredients
  • Special Edition Platinum 10K contains hidden drug ingredients

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)
     

May 1, 2023

• FDA Drug Shortages
  • Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Carboplatin Injection (New - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Dipyridamole Tablets (New - Discontinuation)
  • Furosemide Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• FDA warns consumers to not purchase or use Nose Slap and Soul Slap products marketed for alertness and energy boosting

April 28, 2023

• FDA Drug Shortages
  • 0.9% Sodium Chloride Irrigation (New - Currently in Shortage)
  • Carboplatin Injection (New - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Difluprednate Ophthalmic Emulsion (Updated - Currently in Shortage)
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) Injection (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Prazosin Hydrochloride Capsules (New - Discontinuation)
  • Sterile Water for Irrigation (New - Currently in Shortage)

April 26, 2023

• FDA Drug Shortages
  • Clindamycin Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine 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)
  • Nicotrol (Nicotine) Inhaler (New - Discontinuation)
  • Penicillin G Benzathine Injectable Suspension (New - 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)
• La FDA actualiza la información sobre la prescripción de todos los analgésicos opioides para ofrecer orientaciones adicionales sobre su uso seguro

April 25, 2023

• Drugs@FDA Data Files (updated)
• FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
• Patent Certifications and Suitability Petitions (UPDATED)

April 24, 2023

• FDA Drug Shortages
  • Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) Injection (Updated - Currently in Shortage)
• Regulatory Education for Industry (REdI) Annual Conference 2023

April 19, 2023

• FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma
• Impact Story: New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability
• Public Notifications:
  • DYNAMITE Male Sexual Enhancement contains hidden drug ingredients
  • NUX Male Enhancement contains hidden drug ingredients
  • Pro Power Knight Plus 2550mg contains hidden drug ingredients
• Draft Guidance: Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment

April 18, 2023

• Drugs@FDA Data Files (updated)
• Antifungal Susceptibility Test Interpretive Criteria: Rezafungin Injection
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Cisplatin Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (New - Currently in Shortage)
  • Testosterone Cypionate Injection (New - Discontinuation)

April 17, 2023

• CDER Conversations: The Office of New Drugs' Efforts to Expand Regulatory Science Research
• FDA Drug Shortages
  • Digoxin Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)

April 14, 2023

• Drugs@FDA Data Files (updated)
• Drug Trial Snapshot: EMPAVELI
• Competitive Generic Therapy Approvals (updated)
• 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)

April 13, 2023

• Drug Trial Snapshot: JEMPERLI
• Drug Trials Snapshots: QELBREE
• FDA Drug Shortages
  • Methotrexate Injection (New - Currently in Shortage)
• Notable Approvals | Drugs

• Public Notification: AK Forte contains hidden drug ingredients
• SBIA Webinar: An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
• FDA announces new safety label changes for opioid pain medicines
• Drug Safety Communication: FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use
• FDA Drug Shortages
  • Albuterol Sulfate Inhalational Aerosol, Metered (New - Discontinuation)
  • Cisplatin Injection (Updated - Currently in Shortage)
  •  
  • Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)

April 12, 2023

• Draft Guidance: Over-the-Counter Monograph Order Requests: Format and Content
• Draft Guidance: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
• Draft Guidance: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry
• FDA Drug Shortages
  • Clonazepam Tablets (Updated - Currently in Shortage)
  • Epinastine Hydrochloride Ophthalmic Solution (New - Discontinuation)

April 11, 2023

• Drugs@FDA Data Files (updated)