December 29, 2021

• Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for Human Drugs (updated)
• Drug Shortages (12/28/2021)
  • Amino Acids (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Cefazolin Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)

December 28, 2021

• Drugs@FDA Data Files (updated)
• Patent Certifications and Suitability Petitions (updated)

December 27, 2021

• CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19 - Bamlanivimab and Etesevimab CDER Review (154 KB)
• Drug Shortages
  • Dexmedetomidine Injection (New - Currently in Shortage)
  • Propofol Injectable Emulsion (Updated - Currently in Shortage)
  • Triamcinolone Acetonide Injectable Suspension (Updated - Currently in Shortage)
• FDA Urges Manufacturers to Develop Solutions for iPLEDGE REMS Website
• Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers (updated)
• Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse (updated)

December 23, 2021

• FDA Drug Shortages
  • Ambrisentan Tablets (New - Discontinuation)

December 22, 2021

• FDA approves add-on therapy to lower cholesterol among certain high-risk adults
• Generic Drugs Program Activities Report - Monthly Performance
• FDA Drug Shortages
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Rifampin Capsules (New - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (New - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• Manual of Policies and Procedures (MAPP) 5019.1 Rev.1 Allowable Excess Volume/Content in Injectable Drug and Biological Products
• Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Guidance for Industry

December 21, 2021 

• Drugs@FDA Data Files (updated)

December 17, 2021

• FDA Drug Competition Action Plan (updated)
• FDA approves drug to treat sickle cell disease in patients aged 4 up to 11 years (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)
  • Ketamine Injection (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Vecuronium Bromide for Injection (Updated - Currently in Shortage)
• Curriculum Materials for Health Care Degree Programs | Biosimilars (new)
• CDER Conversation: CDER Creates New Biosimilars Resources for Educators, Teaching Facilities (new)

December 16, 2021

• FDA Drug Shortages
  • Amitriptyline Hydrochloride Tablets (New - Discontinuation)
  • Atropine Sulfate Injection (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)
  • Chloroprocaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Cytarabine Injection (Updated - Currently in Shortage)
  • Dacarbazine Injection (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Dexmedetomidine Injection (Updated - Currently in Shortage)
  • Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
  • Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Furosemide Injection (Updated - Currently in Shortage)
  • Gentamicin Sulfate 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)
  • 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)
  • Midazolam Injection (Updated - Currently in Shortage)
  • Misoprostol Tablets (Updated - Currently in Shortage)
  • Morphine Sulfate Injection (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
  • Pramipexole Dihydrochloride Extended Release Tablets (New - Discontinuation) 
  • Protamine Sulfate Injection (Updated - Currently in Shortage)
  • Rifampin Injection (Updated - Currently in Shortage)
  • Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Sterile Water for Injection (Updated - Currently in Shortage)
  • Sulfasalazine Tablets (Updated - Currently in Shortage)
• Inspection of Injectable Products for Visible Particulates, Guidance for Industry

December 15, 2021

• Competitive Generic Therapy Approvals (updated)
• FDA Drug Shortages
  • Hydroxocobalamin Injection (Updated - Currently in Shortage)
  • Lipid Injection (Updated - Currently in Shortage)
  • Methylprednisolone Acetate Injection (New - Currently in Shortage)
• Fetal Pharmacology and Therapeutics October 21 - 22, 2021 (updated)

December 14, 2021

• Drugs@FDA Data Files (updated)
• Gilead Issues A Voluntary Nationwide Recall of Two Lots of Veklury (Remdesivir) Due to Presence of Glass Particulates

December 13 2021

• Pediatric Exclusivity Granted (updated)

December 10, 2021

• Pediatric Exclusivity Granted (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)
• Prescription to Over-the-Counter (OTC) Switch List (updated)
• FDA Drug Shortages
  • Levoleucovorin Calcium Pentahydrate Injection (New - Discontinuation)
  • Sodium Chloride 0.9% Injection Bags (New - Currently in Shortage)
  • Triamcinolone Acetonide Injectable Suspension (Updated - Currently in Shortage)
• Tainted Sexual Enhancement Products
• How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product 
• Guidance for Industry
  • Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry
  • Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products
  • Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry

December 9, 2021

• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Calcium Gluconate Injection (Updated - Currently in Shortage)
  • Calcium Gluconate Injection (New - Currently in Shortage)
  • Midazolam Injection (New - Currently in Shortage)
• Guidance for Industry:
  • Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment
  • Development of Anti-Infective Drug Products for the Pediatric Population
  • CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports
  • Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
• Manual of Policies and Procedures (MAPP) 4512.2 Rev.2 Conducting Effective Meetings in CDER: Remote Access Considerations 

December 8, 2021

• FDA Drug Shortages
  • Bacteriostatic 0.9% Sodium Chloride Injection (Updated - Currently in Shortage)
  • Cytarabine Injection (Updated - Currently in Shortage)
  • Sterile Water for Injection (New - Currently in Shortage)
  • Sterile Water for Injection (Updated - Currently in Shortage)
  • Triamcinolone Hexacetonide Injectable suspension (Updated - Currently in Shortage)
• Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution USP 4% Due to Super Potency

December 7, 2021

• Drugs@FDA Data Files (updated)
• What's New in Regulatory Science (updated)
• Guidance for Industry:
  • Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators

  • Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations

December 6, 2021

• FDA Drug Shortages
  • Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
  • Parathyroid Hormone (Natpara) Injection (Updated - Currently in Shortage)

December 3, 2021

• Manual of Policies and Procedures (MAPP)
  • 6050.1 Rev 2 Effect of Failure to Pay PDUFA Fees
  • 6050.2 Effect of Failure to Pay BsUFA Fees
• FDA approves rituximab plus chemotherapy for pediatric cancer indications
• FDA approves pembrolizumab for adjuvant treatment of Stage IIB or IIC melanoma

December 2, 2021

• New In Vitro Methods to Understand and Mitigate Clinical Variability Associated with Injectable Suspensions
• FDA Drug Shortages
  • Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
  • Sterile Water for Injection (New - Currently in Shortage)

December 1, 2021

• Good clinical practice collaboration with international regulators (updated)
• FDA approves pafolacianine for identifying malignant ovarian cancer lesions
• FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma 
• FDA Drug Shortages
  • Amino Acids (Updated - Currently in Shortage)
  • Cytarabine Injection (Updated - Currently in Shortage)
  • Megestrol Acetate Suspension (New - Discontinuation)

November 30, 2021

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Amphetamine Oral Suspension, Extended Release (New - Currently in Shortage)
  • Betamethasone Valerate Topical Foam (New - Discontinuation)
  • Clonidine Hydrochloride Extended Release Tablets (New - Discontinuation)
  • Febuxostat Tablets (New - Discontinuation)
  • Sterile Water for Injection (New - Currently in Shortage)
• Generic Drug Research Priorities & Projects (updated)