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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
March 13, 2024
- Draft Guidance for Industry: E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
March 12, 2024
- Drugs@FDA Data Files (Updated)
- Draft Guidance: Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products
March 11, 2024
- Drug Trials Snapshots: ORSERDU
- Drug Trials Snapshots: APHEXDA
- FDA issues guidance regarding drug development for early Alzheimer’s disease
- Draft Guidance: Early Alzheimer’s Disease: Developing Drugs for Treatment
March 8, 2024
- Generic Drugs Program Monthly and Quarterly Activities Report (Updated)
- Orange Book
- FDA Drug Shortages
- Penicillin G Benzathine Injection (Updated - Currently in Shortage)
March 7, 2024
- FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma
- FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma
- FDA Drug Shortages
- Methylphenidate Hydrochloride Tablet, Extended Release (New - Currently in Shortage)
- Methylphenidate Hydrochloride Tablet, Extended Release (Updated - Currently in Shortage)
March 6, 2024
- FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia
- FDA Drug Shortages
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Fluconazole Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Currently in Shortage)
- Furosemide Injection (Updated - Discontinuation)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Final Guidance: Q14 Analytical Procedure Development
March 5, 2024
- Drugs@FDA Data Files (Updated)
- FDA Drug Shortages
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Updated - Currently in Shortage)
- Carboplatin Injection (Updated - Currently in Shortage)
- Cefixime Capsule (Updated - Currently in Shortage)
- Cisplatin Injection (Updated - Currently in Shortage)
- Dexmedetomidine Hydrochloride Injection (Updated - Currently in Shortage)
- Etomidate Injection (Updated - Currently in Shortage)
- Ketamine Hydrochloride Injection (Updated - Currently in Shortage)
- Lisdexamfetamine Dimesylate Capsule (Updated - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Currently in Shortage)
- Methylphenidate Hydrochloride Tablet, Extended Release (Updated - Currently in Shortage)
- Metronidazole Injection (Updated - Currently in Shortage)
- Morphine Sulfate Tablet, Extended Release (New - Discontinuation)
- Naltrexone Hydrochloride Tablet (Updated - Currently in Shortage)
- Nitroglycerin Injection (Updated - Currently in Shortage)
- Quinapril Hydrochloride Tablet (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Sterile Water Injection (Updated - Currently in Shortage)
- Technetium TC-99M Pyrophosphate Kit Injection (Updated - Currently in Shortage)
- Triamcinolone Acetonide Injection (Updated - Currently in Shortage)
- Vecuronium Bromide Injection (Updated - Currently in Shortage)
March 4, 2024
- FDA Drug Shortages
- Carboplatin Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Injection (New - Currently in Shortage)
March 1, 2024
- FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications
- FDA Drug Shortages
- Insulin (human) Injection (New - Discontinuation)
February 29, 2024
- FDA Drug Shortages
- Naltrexone Hydrochloride Tablet (New - Currently in Shortage)
- Public Notifications:
- Workshop: Natural History Studies and Registries in the Development of Rare Disease Treatments
- Final Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry
February 28, 2024
- FDA Drug Shortages
- Phenytoin Oral Suspension (New - Discontinuation)
February 27, 2024
- Drugs@FDA Data Files (Updated)
- FDA Drug Shortages
- Clindamycin Phosphate Injection (Updated - Currently in Shortage)
- Dexmedetomidine Hydrochloride Injection (Updated - Currently in Shortage)
- Disopyramide Phosphate Capsule (Updated - Currently in Shortage)
- Epinephrine Injection (Updated - Currently in Shortage)
- Methylprednisolone Acetate Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection (Updated - Currently in Shortage)
- Penicillin G Benzathine Injection (Updated - Currently in Shortage)
- Quinapril Hydrochloride Tablet (Updated - Currently in Shortage)
- Quinapril/Hydrochlorothiazide Tablet (Updated - Currently in Shortage)
- Somatropin Injection (Updated - Currently in Shortage)
- Sulfasalazine Tablet (Updated - Currently in Shortage)
- Trimethobenzamide Hydrochloride Capsule (Updated - Resolved)
February 26, 2024
- CDER Conversations: Setting and Implementing Standards for Narrow Therapeutic Index Drugs
- FDA Drug Topics: Tips to Navigating Drug Interaction Information in the US Prescribing Information - February 27, 2024
- Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide (Updated)
February 23, 2024
- FDA Drug Shortages
- Melphalan Tablet (New - Discontinuation)
- Methamphetamine Hydrochloride Tablet (Updated - Currently in Shortage)
February 22, 2024
February 21, 2024
- FDA Drug Shortages
- Conivaptan Hydrochloride Injection (Updated - Currently in Shortage)
- Final Guidance: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment
February 20, 2024
- Drugs@FDA Data Files (Updated)
- FDA Drug Shortages
- Mannitol Injection (Updated - Resolved)
- Remifentanil Hydrochloride Injection (Updated - Currently in Shortage)
- GDUFA Implementation Quarterly Meetings between FDA and Industry (Updated)
February 16, 2024
- FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer
- FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma
- Drug Trials Snapshots: AGAMREE
- Drug Trials Snapshots: BRENZAVVY
February 15, 2024
- Drug Trials Snapshots: BIMZELX
- Drug Trials Snapshots: BEYFORTUS
- FDA Drug Shortages
- Mepivacaine Hydrochloride Injection (Updated - Resolved)
- Upcoming Product-Specific Guidances for Generic Drug Product Development (Updated)
February 14, 2024
- Education Efforts to Help Increase Biosimilar Understanding and Acceptance
- FDA Drug Shortages
- Rocuronium Bromide Injection (New - Currently in Shortage)
February 13, 2024
- Drugs@FDA Data Files (Updated)
- FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma
- FDA Drug Shortages
- Gentamicin Sulfate Injection (Discontinuation)
- Morphine Sulfate Injection (Currently in Shortage)
February 12, 2024
- Draft Guidance: Use of Data Monitoring Committees in Clinical Trials
February 9, 2024
- FDA Drug Shortages
- Bupivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Updated - Currently in Shortage)
- Dextrose Monohydrate Injection (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Epinephrine Bitartrate, Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Ketamine Hydrochloride Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride Injection (Updated - Currently in Shortage)
- Lorazepam Injection (Updated - Currently in Shortage)
- Mannitol Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Currently in Shortage)
- Midazolam Hydrochloride Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Sodium Chloride 14.6% Injection (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sterile Water Injection (Updated - Currently in Shortage)
- Orange Book
- Approved Drug Products with Therapeutic Equivalence Evaluations
- 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)
February 8, 2004
- FDA Drug Shortages
- Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)
- Lisdexamfetamine Dimesylate Tablet, Chewable (Currently in Shortage)