April 29, 2022

• FDA Drug Shortages
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Ibutilide Fumarate Injection (New - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
  • Technetium Tc 99m Sulfur Colloid Injection (Updated - Resolved)

April 28, 2022

• Draft Guidance for Industry: Crohn’s Disease: Developing Drugs for Treatment
• Draft Guidance for Industry: Ulcerative Colitis: Developing Drugs for Treatment

April 27, 2022

• CDER Conversations: Disclosing Information About Drugs and Fostering CDER’s Transparency Efforts
• FDA Drug Shortages
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) and Dextrose Injection Solution-Premix Bags (Updated - Currently in Shortage)
  • Lipid Injection (Updated - Currently in Shortage)
  • Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
• Final Guidance for Industry: Providing Submissions in Electronic Format — Postmarketing Safety Reports

April 26, 2022

• FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy
• Regulatory Education for Industry (REdI) Annual Conference 2022
• Drugs@FDA Data Files (updated)

April 25, 2022

• Public Notifications:
  • Kingdom Honey Royal Honey VIP contains hidden drug ingredient
  • Cougar Secret Honey VIP contains hidden drug ingredient
  • Medcare Golden Royal Honey contains hidden drug ingredient
  • HoneyGizer™ contains hidden drug ingredient
  • ETUMAX VIP Royal Honey for Him contains hidden drug ingredients
  • Erkexin contains hidden drug ingredient
  • Royal Honey VIP contains hidden drug ingredient
  • Secret Miracle Honey (For Men) contains hidden drug ingredient
  • Secret Miracle Honey (For Women) contains hidden drug ingredient
  • Vital Honey contains hidden drug ingredient
  • UPDATED: Helmi’s Honey VIP contains hidden drug ingredient
  • UPDATED: X Rated Honey For Men contains hidden drug ingredient

April 22, 2022

• FDA Drug Shortages
  • Fluvoxamine ER Capsules (Updated - Currently in Shortage)

April 21, 2022

• FDA and Duke-Margolis Virtual Public Workshop - Translational Science in Drug Development: Surrogate Endpoints, Biomarkers, and More
• FDA Drug Shortages
  • Dexmedetomidine Injection (Updated - Currently in Shortage)

April 20, 2022

• CDER Alert: FDA warns consumers not to purchase or use Artri and Ortiga products, which may contain hidden drug ingredients
• FDA Drug Shortages
  • Cefazolin Injection (New - Currently in Shortage)
  • Cefazolin Injection (Updated - Currently in Shortage)
  • Methylprednisolone Acetate Injection (New - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (New - Currently in Shortage)
  • Varenicline Tartrate (Chantix) Tablets (New - Currently in Shortage)
  • Varenicline Tartrate (Chantix) Tablets (Updated - Currently in Shortage)
• Public Notifications:
  • Artri King contains hidden drug ingredients
  • Ortiga Mas Ajo Rey contains hidden drug ingredient
  • Ortiga Mas Ajo Rey Extra Forte contains hidden drug ingredients
• CDER SBIA Newsletter and podcast - The Key Elements of Being “Recall-Ready” (new)
• Patent Certifications and Suitability Petitions (updated)
• Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (updated)

April 19, 2022

• Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance
• Drugs@FDA Data Files (updated)

April 18, 2022

• Updated: Competitive Generic Therapy Approvals
• Compounding Quality Center of Excellence On-demand Training

April 15, 2022

• Draft Guidance for Industry: Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet (New)
• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Furosemide Injection (Updated - Currently in Shortage)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Metronidazole Injection (Updated - Currently in Shortage)
  • Rifampin Capsules (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)

April 14, 2022

• Draft Guidance for Industry: Bioavailability Studies Submitted in NDAs or INDs – General Considerations (Updated)
• Bioavailability Guidance Snapshot and Podcast
  • Snapshot
  • Recap Podcast
  • Recap Podcast Transcript
• FDA Drug Shortages
  • Vitamin A Palmitate (Aquasol A) Injection (Updated - Resolved)

April 13, 2022

• Draft Guidance for Industry: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use (New)
• Guidance Documents and MAPPs (BsUFA)
• FDA Drug Shortages
  • Diflunisal Tablets (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
• Webinar: Proposed Rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers

April 12, 2022

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Acetazolamide Injection (New - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Temozolomide Capsules (New - Discontinuation)
• Guidance: Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (Revised Final)

April 11, 2022

• FDA Drug Shortages
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Furosemide Oral Solution (New - Discontinuation)
  • Metronidazole Injection (New - Currently in Shortage)
  • Oxybutynin Chloride Syrup (New - Discontinuation)
  • Valproic Acid Oral Solution (New - Discontinuation)

April 8, 2022

• E8(R1) General Considerations for Clinical Studies
• FDA Drug Shortages
  • Acetazolamide Injection (Updated - Currently in Shortage)
  • Amino Acids (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Bumetanide Injection (Updated - Currently in Shortage)
  • Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride Injection (New - Discontinuation)
  • Diltiazem Hydrochloride Injection (Updated - Currently in Shortage)
  • Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Indapamide Tablets (New - Discontinuation)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Memantine Hydrochloride Extended-Release Capsules (New - Discontinuation)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Nystatin and Triamcinolone Acetonide Cream (New - Discontinuation)
  • Nystatin and Triamcinolone Acetonide Ointment (New - Discontinuation)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Sterile Water for Injection (Updated - Currently in Shortage)
• 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 7, 2022

• FDA Drug Shortages
  • Methyldopa Tablets (Updated - Currently in Shortage)
• US-Canada Regional ICH Consultation
• Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Guidance for Industry

April 6, 2022

• Drugs@FDA Data Files (updated)
• FDA Workshop on the Role of Phytosterols in PNALD/IFALD
• FDA approves alpelisib for PIK3CA-related overgrowth spectrum
• FDA Drug Shortages
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• Guidance for Industry:
  • M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES
  • Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment

April 5, 2022

• Drugs@FDA Data Files (updated)
• Quality Management Maturity Workshop

April 1, 2022

• FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma
• FDA Drug Shortages
  • Amino Acids (Updated - Currently in Shortage)
  • Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride and Epinephrine Injection (Updated - Currently in Shortage)
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Calcium Gluconate 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 10% Injection (Updated - Currently in Shortage)
  • Dextrose 5% Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Gentamicin Sulfate Injection (Updated - Currently in Shortage)
  • Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
  • Imipenem and Cilastatin for Injection (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Leuprolide Acetate Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
  • Lipid Injection (Updated - Currently in Shortage)
  • Mepivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Rifampin Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Sodium Phosphates Injection (Updated - Currently in Shortage)
  • Sterile Water for Injection (Updated - Currently in Shortage)
  • Valproate Sodium Injection (Updated - Currently in Shortage)

March 31, 2022

• FDA Drug Shortages
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Semaglutide (WEGOVY®) Injection (New - Currently in Shortage)
• Online Verification of eCPPs for Human Drug Products

March 30, 2022

• FDA warns patients and health care professionals not to use sterile products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding
• FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging
• Pharmaceutical Quality/Chemistry, Manufacturing & Controls (PQ/CMC)

March 29, 2022

• Drugs@FDA Data Files (updated)