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Updated Monday through Friday
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- Draft Guidance for Industry: Crohn’s Disease: Developing Drugs for Treatment
- Draft Guidance for Industry: Ulcerative Colitis: Developing Drugs for Treatment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:
- 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
- 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:
April 5, 2022
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)