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- Drug Firm Annual Registration Status
- Drug Firm Annual Registration Status Download File
- National Drug Code Directory
- NDC Unfinished Drugs Excluded Database File
- NDC Database Excluded Packages and Products
- Wholesale Distributor and Third-Party Logistics Providers Reporting
October 17, 2023
- FDA Drug Shortages
- Colestipol Hydrochloride Granule (New - Discontinuation)
- Technetium Tc-99m Sodium Pertechnetate Generator (New - Discontinuation)
- Toward Global IDMP Implementation: A Focus on Global Use Cases
- CDER soliciting comments regarding clinical trial innovation
- Drugs@FDA Data Files (Updated)
- Competitive Generic Therapy Approvals (updated)
October 16, 2023
- A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Workshop
- Draft Guidance: Diabetic Foot Infections: Developing Drugs for Treatment
- Final Guidance: Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
- FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer
October 13, 2023
- Event: FDA Clinical Investigator Training Course (CITC) 2023
- FDA Drug Shortages
- Streptozocin Powder, For Solution (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)
- iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) (Updated)
October 12, 2023
- Drug Trials Snapshots: ENJAYMO
- Draft Guidance: Quality Considerations for Topical Ophthalmic Drug Products
- FDA Drug Shortages
- Neomycin Sulfate Tablet (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Tirzepatide Injection (Updated - Currently in Shortage)
October 11, 2023
- FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation
- FDA Drug Shortages
- Difluprednate Emulsion (Updated- Currently in Shortage)
October 10, 2023
- Drugs@FDA Data Files (Updated)
- FDA warns patients and health care providers about potential risks associated with compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders
October 6, 2023
- FDA Drug Shortages
- Nitroglycerin Injectable (New - Currently in Shortage)
October 4, 2023
- Drug Trials Snapshot: LIVMARLI
- Drug Trials Snapshot: BYLVAY
- CDER Takes Measures to Tackle Stimulant Use Disorder
- Draft Guidance: Stimulant Use Disorders: Developing Drugs for Treatment
- FDA Drug Shortages
- LISDEXAMFETAMINE DIMESYLATE CAPSULE (Updated - Currently in Shortage)
October 3, 2023
- Drugs@FDA Data Files (Updated)
- FDA Drug Shortages
- Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Lisdexamfetamine Dimesylate Capsule (Updated - Currently in Shortage)
- Lisdexamfetamine Dimesylate Tablet, Chewable (Updatd - Currently in Shortage)
October 2, 2023
- Drug Trials Snapshots: ZTALMY
- FDA Drug Shortages
- Leucovorin Calcium Injection (Updated - Currently in Shortage)
- Remifentanil Hydrochloride Injection, Powder, Lyophilized, For Solution (Updated - Currently in Shortage)
September 29, 2023
- Generic Competition and Drug Prices (updated)
- FDA Drug Shortages
- Cyclosporine Injection (New - Discontinuation)
- Final Guidance: Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”
- Public Notifications:
September 27, 2023
- Drug Trials Snapshots: KORSUVA
- FDA Drug Shortages
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection (Updated - Currently in Shortage)
September 26, 2023
September 25, 2023
- Conference: Defining 'Candy-Like' Nonprescription Drug Products
- Abbreviated New Drug Application (ANDA) Forms and Submission Requirements (Updated)
- Drug Trials Snapshots: SOTYKTU
September 22, 2023
- FDA Drug Shortages
- LISDEXAMFETAMINE DIMESYLATE CAPSULE (Updated - Currently in Shortage)
September 21, 2023
- Draft Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
- Draft Guidance: Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
- FDA issues guidance on using remote oversight tools to help approve drugs
September 20, 2023
- Final Guidance: Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies
- FDA Drug Shortages
- LISDEXAMFETAMINE DIMESYLATE CAPSULE (Updated - Currently in Shortage)
- LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE (Updated - Currently in Shortage)
September 19, 2023
- Competitive Generic Therapy Approvals (updated)
- Drugs@FDA Data Files (Updated)
- Drug Trials Snapshots: LYBALVI
- Drug Trials Snapshots: ADBRY
- Drug Trials Snapshots: ELUCIREM
- FDA Drug Shortages
- I.V. Fat Emulsion (Updated - Currently in Shortage)
September 18, 2023
- CDER Alert: FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules
- Draft Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
- Draft Guidance: Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
- FDA issues draft guidance regarding confirmatory evidence of clinical trials
- FDA Drug Shortages
- Cisplatin Injection (Updated - Currently in Shortage)
- EPINEPHRINE SOLUTION (New - Discontinuation)
- Ketamine Hydrochloride Injection (Updated - Currently in Shortage)