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Updated Monday through Friday
- CDER Launches New Accelerating Rare disease Cures (ARC) Program
- 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
May 5, 2023
- FDA 更新了所有阿片類止痛藥的處方信息,以提供額外的安全使用指南
- Public Notifications:
- Phentamene XT contains hidden drug ingredient
- Honey Girl contains hidden drug ingredient
- Infinity 10K contains hidden drug ingredients
- Infinity contains hidden drug ingredient
- Mega 9K 800000 contains hidden drug ingredients
- Meta Forte contains hidden drug ingredients
- Natural MiracleZEN GOLD 60000 contains hidden drug ingredients
- XXX Zone 40K contains hidden drug ingredients
- MEGA 7G 700000 contains hidden drug ingredients
- Mr. Strong Guy Honey For Him contains hidden drug ingredient
- Platinum 69000 Rhino 69 contains hidden drug ingredient
- Power Plus Desire contains hidden drug ingredient
- Rhino 7S Type F3 7000 contains hidden drug ingredients
May 4, 2023
- FDA Drug Shortages
- Dulaglutide (Trulicity) Injection (Updated - Currently in Shortage)
- Semaglutide (WEGOVY®) Injection (Updated - Currently in Shortage)
- Zoledronic Acid Injection (New - Discontinuation)
- Public Notifications
May 3, 2023
- Competitive Generic Therapy Approvals (updated)
- Q9(R1) Quality Risk Management (updated)
May 2, 2023
- Drugs@FDA Data Files (updated)
- Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (updated)
- Health Communications Specialist Careers at CDER
- Writer/Editor Careers at CDER
- Technical Information Specialist Careers at CDER
- Business Informatics Specialist Careers at CDER
- Data Scientist Careers at CDER
- General Health Scientist Careers at CDER
- Health Science Policy Analyst Careers at CDER
- Pharmaceutical Scientist Careers at CDER
- Pharmacokineticist Careers at CDER
- Social Science Analyst Careers at CDER
- Biologist Careers at CDER
- Engineering Careers at CDER
- Clinical Analyst Careers at CDER
- Draft Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
- FDA Drug Shortages
- Remifentanil Injection (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)
May 1, 2023
- FDA Drug Shortages
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Carboplatin Injection (New - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dipyridamole Tablets (New - Discontinuation)
- Furosemide Injection (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Vecuronium Bromide for Injection (Updated - Currently in Shortage)
- FDA warns consumers to not purchase or use Nose Slap and Soul Slap products marketed for alertness and energy boosting
April 28, 2023
- FDA Drug Shortages
- 0.9% Sodium Chloride Irrigation (New - Currently in Shortage)
- Carboplatin Injection (New - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Difluprednate Ophthalmic Emulsion (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) Injection (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Prazosin Hydrochloride Capsules (New - Discontinuation)
- Sterile Water for Irrigation (New - Currently in Shortage)
April 26, 2023
- FDA Drug Shortages
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- IV Fat Emulsion ((Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Nicotrol (Nicotine) Inhaler (New - Discontinuation)
- Penicillin G Benzathine Injectable Suspension (New - Currently in Shortage)
- Rocuronium Bromide Injection ((Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection ((Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags ((Updated - Currently in Shortage)
- La FDA actualiza la información sobre la prescripción de todos los analgésicos opioides para ofrecer orientaciones adicionales sobre su uso seguro
April 25, 2023
- Drugs@FDA Data Files (updated)
- FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
- Patent Certifications and Suitability Petitions (UPDATED)
April 24, 2023
- FDA Drug Shortages
- Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) Injection (Updated - Currently in Shortage)
- Regulatory Education for Industry (REdI) Annual Conference 2023
April 19, 2023
- FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma
- Impact Story: New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability
- Public Notifications:
- Draft Guidance: Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment
April 18, 2023
- Drugs@FDA Data Files (updated)
- Antifungal Susceptibility Test Interpretive Criteria: Rezafungin Injection
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (New - Currently in Shortage)
- Testosterone Cypionate Injection (New - Discontinuation)
April 17, 2023
- CDER Conversations: The Office of New Drugs' Efforts to Expand Regulatory Science Research
- FDA Drug Shortages
- Digoxin Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
April 14, 2023
- Drugs@FDA Data Files (updated)
- Drug Trial Snapshot: EMPAVELI
- Competitive Generic Therapy Approvals (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)
- Appendix A: Product Name Index (updated)
- Appendix B: Product Name Sorted by Applicant (updated)
- Appendix C: Uniform Terms (updated)
April 13, 2023
- Drug Trial Snapshot: JEMPERLI
- Drug Trials Snapshots: QELBREE
- FDA Drug Shortages
- Methotrexate Injection (New - Currently in Shortage)
- Notable Approvals | Drugs
- Public Notification: AK Forte contains hidden drug ingredients
- SBIA Webinar: An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
- FDA announces new safety label changes for opioid pain medicines
- Drug Safety Communication: FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use
- FDA Drug Shortages
- Albuterol Sulfate Inhalational Aerosol, Metered (New - Discontinuation)
- Cisplatin Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
April 12, 2023
- Draft Guidance: Over-the-Counter Monograph Order Requests: Format and Content
- Draft Guidance: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
- Draft Guidance: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry
- FDA Drug Shortages
- Clonazepam Tablets (Updated - Currently in Shortage)
- Epinastine Hydrochloride Ophthalmic Solution (New - Discontinuation)
April 11, 2023
- Drugs@FDA Data Files (updated)
April 7, 2023
- Public Notifications
April 6, 2023
- Compounding Safety Information: Quinacrine Hydrochloride
- FDA Drug Shortages
- Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
- IV Fat Emulsion (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Mycophenolic Sodium Delayed-Release Tablets (New - Discontinuation)
- Potassium Chloride Concentrate Injection (Updated - Currently in Shortage)
April 5, 2023
- Public Webinar Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making – Draft Guidance
- Draft Guidance: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
- Draft Guidance: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act
- FDA Drug Shortages
- Amoxicillin Oral Powder for Suspension (Updated - Currently in Shortage)
- Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage)
- Calcium Acetate Oral Solution (New - Discontinuation)
- Capecitabine Tablets (Updated - Currently in Shortage)
- Chloramphenicol Sodium Succinate Injection (New - Currently in Shortage)
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Clonazepam Tablets (Updated - Currently in Shortage)
- Ethinyl Estradiol / Norethindrone Acetate and Ferrous Fumarate Tablets (New - Discontinuation)
- Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection (Updated - Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Updated - Currently in Shortage)
- Semaglutide (Ozempic) Injection (Updated - Currently in Shortage)
- Streptozocin (Zanosar) Sterile Powder (Updated - Currently in Shortage)
- Sulfasalazine Tablets (Updated - Currently in Shortage)