July 15, 2022

• FDA Drug Shortages
  • Rifampin Capsules (Updated - Currently in Shortage)
• Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format (Final Guidance)

July 14, 2022

• FDA approves crizotinib for ALK-positive inflammatory myofibroblastic tumor
• FDA 警告癌症药物 Copiktra（duvelisib 杜韦利西布）可能会增加死亡风险和有严重的副作用
• FDA Drug Shortages
  • Fludarabine Phosphate Injection (Updated - Currently in Shortage)
  • Iohexol Injection (Updated - Currently in Shortage)
  • Iomeprol Injection (New - Currently in Shortage)

July 13, 2022

• Mitigating Risks of Compounded Drugs Through Surveillance (updated)
• La FDA advierte sobre un posible aumento del riesgo de muerte y efectos secundarios graves con el medicamento contra el cáncer Copiktra (duvelisib)
• Competitive Generic Therapy Approvals (updated)
• FDA Drug Shortages
  • Vandetanib Tablets (New - Currently in Shortage)

July 12, 2022

• Drugs@FDA Data Files (updated)
• Drugs@FDA Download File (updated)
• FDA Drug Shortages
  • Bivalirudin in 0.9% Sodium Chloride Injection (New - Discontinuation)
  • Pentostatin Injection (Updated - Currently in Shortage)
  • Streptozocin (Zanosar) Sterile Powder (New - Currently in Shortage)

July 11, 2022

• Conference: Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines

July 8, 2022

• 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)

July 7, 2022

• Drugs@FDA Data Files (updated)
• Drugs@FDA Download File (updated)

July 5, 2022

• Drugs@FDA Data Files (updated)
• Guidance for Industry: Identifying Trading Partners Under the Drug Supply Chain Security Act

June 30, 2022

• Drug Safety Communication: FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)

June 29, 2022

• Condition-Specific Meeting Reports and Other Information Related to Patients' Experience
• Guidance for Industry: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
• Patent Certifications and Suitability Petitions 

June 28, 2022

• Drugs@FDA Data Files (updated)
• Drugs@FDA Download File (updated)
• Remifentanil Injection (Currently in Shortage) (new)
• CDER Conversations (updated)

June 27, 2022

• FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma
• The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use (New)

June 24, 2022

• Guidance for Industry—Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics (Draft)

June 23, 2022

• Guidances for Industry
  • Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (Draft - Revised Final)
  • Considerations for Rescinding Breakthrough Therapy Designation (Draft)
  • Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations (Final)

June 22, 2022

• FDA Drug Shortages
  • Acetic Acid Otic Solution (New - Discontinuation)
  • Ampicillin for Injection (New - Discontinuation)
  • Carbamazepine Oral Suspension (New - Discontinuation)
  • Doxycycline Hyclate Tablets (Updated - Discontinuation)
  • Lindane Shampoo 1% (New - Discontinuation)
  • Lorazepam Injection (Updated - Currently in Shortage)
  • Rifapentine Tablets (Updated - Currently in Shortage)

June 21, 2022

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Doxycycline Hyclate Tablets (New - Discontinuation)
  • Olopatadine Hydrochloride Nasal Spray (New - Discontinuation)

June 17, 2022

• FDA Drug Shortages
  • Acetazolamide Injection (Updated - Resolved)
  • Amino Acids (Updated - Currently in Shortage)
• SBIA Webinar: Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
• SBIA Webinar: Best Practices for Topical Generic Product Development and ANDA Submission

June 16, 2022

• Orange Book Data Files (compressed) (updated)
• Updated: List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
• Competitive Generic Therapy Approvals (updated)
• FDA Drug Shortages
  • Rosuvastatin Calcium Tablets (New - Discontinuation)

June 15, 2022

• FDA Drug Shortages
  • Diazepam Rectal Gel (New - Currently in Shortage)

June 14, 2022

• Draft Guidance for Industry: Q9(R1) Quality Risk Management
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Loxapine Capsules (Updated - Resolved)
  • Sclerosol Intrapleural Aerosol (Updated - Discontinuation)
• Patent Certifications and Suitability Petitions (updated)

June 13, 2022

• Chinese version of Ukoniq DSC: 出于安全关切，FDA撤回对淋巴瘤药物Ukoniq厄布利塞 (乌帕利斯 umbrlisib) 的批准