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Drugs
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What's New (Drugs)
drugsThis page lists recent news items and new and updated pages. Recent New and Generic Drug Approvals appear on a separate page.
Drug Topic Updates:
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November 10, 2009
- IABS/FDA co-sponsored Scientific Conference: Protein Particles and Immunogenicity of Therapeutic Proteins: Filling in the Gaps in Risk Evaluation and Mitigation. November 12-13, 2009, Bethesda, MD. Meeting and Registration Information.
- FDA approves Istodax (romidepsin) for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma
- MedWatch Alert: Hospira Brand Propofol and Liposyn Products - Recall
November 9, 2009
- Drug Shortages: Current Drug Shortages: Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s (updated)
- Guidance for Industry: E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers
November 6, 2009
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BPCA/Pediatric Exclusivity Statistics:
- Pediatric Exclusivity Statistics (updated)
- Written Requests Issued (updated)
- Cancer Drug Development Calculators
- Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
- Emergency Use of Tamiflu in Infants Less than 1 Year of Age (Updated)
- MedWatch Alert: Stiff Nights - product contains undeclared drug ingredient
- MedWatch Alert: Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall
- MedWatch Alert: Bodybuilding.com Brand Dietary Supplements - Sold on Internet
- Paragraph IV Patent Certifications (updated)
- Rulemaking History for Nonprescription Products: Labeling
November 5, 2009
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. Registration for this Nov. 12-13 meeting is closed. A free webcast will be available, no registration necessary. Webcast information
November 4, 2009
- FDA Unveils Safe Use Initiative that Targets Preventable Harm from Medication Use
- Drug Shortages: Current Drug Shortages: Pentothal (thiopental) Injection
- Drugs@FDA Download File (updated)
- Guidance for Industry: Dosage Delivery Devices for OTC Liquid Drug Products (PDF -93 KB)
November 3, 2009
November 2, 2009
- CDER Manual of Policies and Procedures (MaPP)
- Drug Shortages: Drugs to be Discontinued: Faslodex* (fulvestrant) Injection
- Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions
- Information for Healthcare Professionals: Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta)
October 30, 2009
- Guidance for Industry: Individual Product Bioequivalence Recommendations 18 new recommendations added
- FDA issues Procter and Gamble Warning Letter for VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated)
- Drug Shortages: Current Drug Shortages: Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s
- Medication Guides (updated)
- National Drug Code Directory (updated)
- Peramivir IV Questions and Answers for Health Care Providers
- Postmarket Requirements and Commitments (updated)
October 29, 2009
- Drugs@FDA Download File (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
October 28, 2009
- Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection) (updated)
- Drug Shortages: Current Drug Shortages: Methotrexate injection (updated)
- Drug Shortages: Current Drug Shortages: Mitomycin for injection (updated)
- Drug Shortages: Resolved Drug Shortages: Calcium Disodium Versenate Injection 200 mg/mL 5 mL ampules (NDC 29336-400-10)
October 27, 2009
- Draft Guidance for Industry: SPL Standard for Content of Labeling Technical Qs & As (PDF - 56KB)
- Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated)
- Sanofi-Aventis Warning Letter (Product: Uroxatral) (PDF - 72KB)
October 26, 2009
- 4th Annual FDA/DIA Statistics Forum, April 19-21, 2010, Bethesda, MD. Meeting information and registration.
- DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010, Bethesda, MD. Meeting information and registration.
- Drug Shortages: Resolved Drug Shortages: Dexrazoxane for Injection, Zinecard
- FDA Approves New Treatment for Chronic Lymphocytic Leukemia
- MedWatch Alert on Rituxan (rituximab) and progressive multifocal leukoencephalopathy (PML)
October 23, 2009
- Drug Shortages: Resolved Drug Shortages: Oxycodone Immediate Release Tablets (updated)
- Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163 KB)
- Information for Healthcare Professionals - Mandatory Adverse Event Reporting for Emergency Use of Peramivir Under EUA
October 22, 2009
- Warning Letters
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- Drugs@FDA Download File (updated)
October 21, 2009
- Paragraph IV Patent Certifications (updated)
- FDA Approves New Treatment for Advanced Form of Kidney Cancer
- MedWatch Recall Alert for Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials
October 20, 2009
October 19, 2009
- Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
- Drug Shortages: Current Drug Shortages: Fabrazyme (agalsidase beta) (updated)
- Medication Guides (updated) (new: Darvocet, Darvon, Metozolv, Stelara; updated: Cellcept, Myfortic)
October 16, 2009
- Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
- Guidance for Industry: Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 66 KB)
- MedWatch Alert on labeling change for dexferrum (iron dextran injection)
October 15, 2009
- Question and Answers about Changes to the USP Heparin Monograph
- Dissolution Methods Database
- Inactive Ingredient Search for Approved Drug Products (updated)
- Postmarketing Safety Evaluation of New Molecular Entities: Final Report
October 14, 2009
- Drugs@FDA Download File (updated)
- DSOB Memorandum of Meeting Minutes, September 17, 2009
- New FDA Web Page Lists Disposal Instructions for Select Medicines
October 13, 2009
- FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets
- FDA Approves Berinert to Treat Abdominal Attacks, Facial Swelling Associated With Hereditary Angioedema
- MedWatch Safety Alert for Relenza (zanamivir) Inhalation Powder
- Warning Letter
- Drug Shortages: Current Drug Shortages: Fabrazyme (agalsidase beta) (updated)
- Preparation for ICH meetings in St. Louis, Missouri to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in St. Louis, Missouri, Public Meeting, October 14, 2009, Washington Room, Hilton Rockville, 1750 Rockville Pike, Rockville, Maryland (updated)
October 9, 2009
- Drug Shortages: Resolved Drug Shortages: Morphine Sulfate Oral Solution (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Prescription Drug User Fee Act (PDUFA): Address for Courier Delivery of PDUFA User Fee Payments Has Been Updated
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