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May 22, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- National Drug Code Directory
- Presentation: Coming of Age of Personalized Medicine (PDF - 797KB)
- Preventing Surgical Fires: Initiative Partners (updated)
May 21, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- MedWatch Safety Alert: Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials
- National Drug Code Directory
May 20, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- First-Time Generic Drug Approvals - April 2013
- Generic Drugs: Suitability Petition Reports (updated)
- MedWatch Safety Alert: All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance
- National Drug Code Directory
May 17, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- MedWatch Safety Alert: Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance
- National Drug Code Directory
- Orange Book (updated)
- Presentations:
- Challenges of Globalization (PDF - 834KB)
- Adverse Event Reporting and Medication Safety Considerations: A View from CDER’s Office of Surveillance and Epidemiology (PDF - 445KB)
- FDA Perspective: Transformational Initiatives (PDF - 252KB)
- The Regulatory Pathway for Rare Diseases Lessons Learned from Examples of Clinical Study Designs for Small Populations (PDF - 832KB)
- The Value of A Qualified Outcome Measure (PDF - 41KB)
- Spanish Drug Safety Communication: Zolpidem: La FDA aprueba cambios de etiqueta para los productos con zolpidem, que incluyen nueva dosificación y una recomendación de evitar conducir el día posterior al uso de Ambien CR
May 16, 2013
- Drug Firm Annual Registration Status (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
- Medication Guides (updated)
- National Drug Code Directory
- Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) (updated)
May 15, 2013
- FDA Press Release: FDA approves Simponi to treat ulcerative colitis
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Podcast: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use
- National Drug Code Directory
May 14, 2013
- FDA Press Release: FDA approves Nymalize—first nimpdipine oral solution for use in certin brain hemorrhage patients
- Drug Firm Annual Registration Status (updated)
- Drug Safety Oversight Board Meeting, March 21, 2013, Public Summary
- Drugs@FDA Data Files (updated)
- FDA Drug Safety Communication: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use
- Guidance for Industry: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data (PDF - 501KB)
- National Drug Code Directory
May 13, 2013
- Drug Firm Annual Registration Status (updated)
- Manual of Policies and Procedures (MAPP) 4512.2 (PDF - 114KB) Conducting Effective Meetings in CDER: Remote Access Considerations
- National Drug Code Directory
- Spanish Drug Safety Communication:
- Productos con valproato para las convulsiones están contraindicados para la prevención de migrañas en mujeres embarazadas debido a disminución en puntajes de cociente intelectual (IC) en niños expuestos
- Kadcyla: La FDA advierte sobre posibles errores de medicación como resultado de la confusión con respecto a la denominación común del medicamento Kadcyla (ado-trastuzumab emtansina) para el cáncer de mama
May 10, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Statement: Original Opana ER Relisting Determination
- National Drug Code Directory
- Pediatric Exclusivity Statistics (updated)
May 9, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Public Workshop: Clinical Trial Design Issues - Development of New Therapies for Non-Muscle Invasive Bladder Cancer, May 6, 2013, Manchester Grand Hyatt Hotel, Douglas Pavilion C & D, One Market Place, San Diego, CA. Meeting information
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
- Requesting Speakers from CDER
- Warning Letters 2013 (updated)
May 8, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA Press Release: FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop
- Guidance for Industry:
- National Drug Code Directory
May 7, 2013
- FDA Drug Safety Podcast: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children
- Current Drug Shortages Index (updated)
- CDER Director's Mailbag Question on Singulair
- FDA Drug Safety Podcast: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine)
- Prescription Drug User Fee Act (PDUFA): The Dear Colleague Letter (PDF - 54KB), in anticipation of FY 2014 Invoices, was mailed Friday, 5/3/2013. Responses are due by 6/12/2013. If you do not receive the letter by 5/31/2013, please contact Ashley Jones or Beverly Friedman at 301-796-3602.
- Public Notification: “Vicerex” Contains Hidden Drug Ingredient
- Public Notification: “Bullet Proof” Contains Hidden Drug Ingredient
- Public Notification: “Lightning ROD” Contains Hidden Drug Ingredient
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Manual of Policies and Procedures (MAPP) 5000.6R1 Office of Pharmaceutical Science Coordinating Committee (OPS CC) (PDF - 66KB)
- National Drug Code Directory
May 6, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Safety Communication: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children
- National Drug Code Directory (updated)
- Spanish Drug Safety Communication: Samsca (tolvaptán) - La FDA limita la duración y uso de Samsca (tolvaptán) debido a posibles lesiones hepáticas que pueden resultar en necesidad de trasplante de órganos o muerte
- Warning Letters 2013 (updated)
May 3, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (BPCA/FDASIA) (updated)
- National Drug Code Directory (updated)
- Postmarketing Requirements and Commitments Search (updated)
- Postmarketing Requirements and Commitments: Downloadable Database File (updated)
- Spanish Drug Safety Communication: Medicamento anticonvulsivo Potiga (ezogabina) vinculado con anomalías de la retina y decoloración azulada de la piel
May 2, 2013
- Drug Firm Annual Registration Status (updated)
- FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files (updated)
- FAERS Quarterly Data Files Documentation (updated)
- National Drug Code Directory (updated)
May 1, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- FDA News Release: FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older
- FDA Drug Safety Podcast: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death
- National Drug Code Directory (updated)
April 30, 2013
- CDER Billable Biologic Product List (PDF - 48KB)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Safety Podcast: Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration
- Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death
- FDA Listing of Authorized Generics (updated)
- FDA News Release: FDA approves Procysbi for rare genetic condition
- Medication Guides (updated)
- MedWatch Safety Alert - Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall - Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution
- National Drug Code Directory (updated)
- Pediatric Statistics: Pediatric Exclusivity Granted (updated)
- Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): 1 new and 8 updated reports (updated)
April 29, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Manual of Policies and Procedures (MAPP) 6030.9 Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review(PDF - 297KB)
- National Drug Code Directory (updated)
April 26, 2013
- ANDA Suitability Petition Reports (updated)
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Additional News and Information
- FDA Drug Safety Communication: Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration
- First-Time Generic Drug Approvals - 2013 (updated)
- Fraudulent Versions of Botox Found in the United States
- MedWatch Safety Alert: Sodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira: Recall - Particulate Matter
- National Drug Code Directory (updated)
April 25, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory (updated)
- Public Notification: “Sex Plus” Contains Hidden Drug Ingredient
- Public Notification: “Zoom-Zooma-Zoom” Contains Hidden Drug Ingredient
- Guidance for Industry: Regulatory Classification of Pharmaceutical Co-Crystals (PDF - 84KB)
April 24, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Data Files (updated)
- FDA Statement in Support of the 2013 National Drug Control Strategy
- MedWatch Safety Alert: All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance
- National Drug Code Directory (updated)
April 23, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (PDF - 608KB)
- Manual of Policies and Procedures (MAPP) 5015.3 Cover Form for the Technical Review of Drug Master Files (DMFs) (PDF - 47KB)
- National Drug Code Directory (updated)
April 22, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy
- National Drug Code Directory (updated)
- Office of Prescription Drug Promotion (OPDP) Launches (updated)
- Paragraph IV Patent Certifications (updated)
- Safe Use Initiative: Funding and Support (updated)
- Warning Letters 2013 (updated)
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