April 25, 2009Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
See Web site for additional information on this current drug shortage Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated)
Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Source: www.fda.gov Drug Shortages: Current Drug Shortages: Morphine Sulfate Oral Solution Current Drug Shortages: Morphine Sulfate Oral Solution, see Related Information section Source: www.fda.gov April 2009 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Source: www.fda.gov ZOLL AED Plus Defibrillator Class 1 recall because the defibrillator may fail to deliver a shock, and result in failure to resuscitate a patient during treatment of sudden cardiac arrest. Source: www.fda.gov FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) FDA issues Information for Healthcare Professionals: Ceftriaxone (marketed at Rocephin and generics) Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets Current Drug Shortages: Metoprolol succinate extended release tablets, see updated letter in Related Information Section Source: www.fda.gov April 24, 2009Preventing Medical Errors: Preventing Misconnection Errors ? Medical Device Safety Calendar Preventing Medical Errors: Preventing Misconnection Errors ? Medical Device Safety Calendar
FDA has received many reports of patient injuries and deaths when different device delivery systems are mistakenly connected to each other. These errors are often facilitated by fittings called Luer connectors, which allow different systems to be ea... Source: www.accessdata.fda.gov Pistachio Recall Expanded On April 6, 2009, Setton Pistachio, Terra Bella, Calif., expanded its recall of pistachio products. Source: www.fda.gov FDA 101: Clinical Trials and Institutional Review Boards Clinical trials test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Source: www.fda.gov Preventing Medical Errors: Confusing Heparin Labels Can Lead to Errors The Institute for Safe Medication Practices (ISMP) points out that some multiple dose heparin vials have potentially confusing labels that could lead to dangerous overdoses. These vials, which contain 4 mL of heparin solution, are labeled "10,000 US... Source: www.accessdata.fda.gov Preventing Medical Errors: Avoiding Medication Errors with Multiple Brand Names The Institute for Safe Medication Practices (ISMP) recently highlighted medication errors that can occur when a drug is marketed under more than one brand name, especially when one of those names is well established. ISMP describes a case where ... Source: www.accessdata.fda.gov On the Road Again: FDA's Mobile Laboratories This article (with slide show) reveals how mobile labs help FDA test food and drugs for contaminants. Source: www.fda.gov UFDA Approves Monthly Injectable Drug for Treating Three Types of Immune-Related Arthritis UFDA Approves Monthly Injectable Drug for Treating Three Types of Immune-Related Arthritis
The U.S. Food and Drug Administration today approved Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Acyclovir Injection Drug Shortages: Current Drug Shortages: Acyclovir Injection
See Related Information section for updated information Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 No further supply issues are anticipated. See related information section for more information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Triamcinolone Hexacetonide (Aristospan) Triamcinolone Hexacetonide (Aristospan); Manufacturing Delays Source: www.fda.gov Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Related information section for posted letter Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets Current Drug Shortages: Metoprolol succinate extended release tablets, see updated letter in Related Information Section Source: www.fda.gov April 23, 2009Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated)
Updated letter on this current drug shortage Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Methadone Hydrochloride Injection No further supply issues are anticipated Source: www.fda.gov Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets, see Related Information Secrion for updated letter Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection See Web site for additional information Source: www.fda.gov March 2009 Safety Labeling Changes March 2009 Safety Labeling Changes
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. Source: www.fda.gov Guidance for Industry New Revised/Withdrawn List for 2009 Source: www.fda.gov Guidance for Industry Q10 Pharmaceutical Quality System Source: www.fda.gov FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml Source: www.fda.gov April 22, 2009Guidance for Industry Guidance for Industry
New Revised/Withdrawn List for 2009 Source: www.fda.gov Division of Drug Marketing, Advertising, and Communications issues 14 letters Division of Drug Marketing, Advertising, and Communications issues 14 letters Source: www.fda.gov Guidance for Industry Comprehensive List of Guidance Documents Source: www.fda.gov Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry; May 12-13, 2009 Source: www.fda.gov Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; MVI Adult Injectable No further supply issues are anticipated Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch
See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Related information section for posted letter Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Methadone Hydrochloride Injection No further supply issues are anticipated Source: www.fda.gov ZOLL AED Plus Defibrillator Class 1 recall because the defibrillator may fail to deliver a shock, and result in failure to resuscitate a patient during treatment of sudden cardiac arrest. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin See web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection) Elan estimates availability of Azactam 1 gram vials (NDC 51479-0041-15), and 2 gram vials (NDC 51479-0042-15)in March/April time frame. For additional information call Elan at 1-800-859-8586, and Baxter has 1 gram (NDC 51479-0048-01) and 2 gram (NDC 51479-0049-01) frozen aztreonam available on allocation. For additional information call Baxter at 1-888-229-0001. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) - (updated) Increase in demand related to product recalls by other manufacturers Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) Mallinckrodt continues to work diligently to meet the market need during this temporary period of limited supply. Xanodyne has additional releases starting February 20th, 2009. Vintage Pharmaceuticals will be releasing additional product starting February 11th, 2009. Source: www.fda.gov April 21, 2009FDA Approves Benzyl Alcohol Lotion for the Treatment of Head Lice FDA Approves Benzyl Alcohol Lotion for the Treatment of Head Lice
The U.S. Food and Drug Administration today approved a new prescription medication for the treatment of head lice ( Pediculosis capitis ) infestation. Benzyl Alcohol Lotion, 5 Percent, received full market approval as a prescription medication, for use in patients 6 months of age and older. Source: www.fda.gov FDA Serves Warrant for Inspection of Westco Fruit and Nuts Inc. At the request of the U.S. Food and Drug Administration, U.S. Marshals today executed an inspection warrant at Westco Fruit and Nuts Inc. (Westco/Westcott), an Irvington, N.J.-based company. Westco/Westcott did not provide access to distribution documents and declined to recall products after an FDA request. Regulated companies are required by law to grant FDA entry for inspection, as well as provide access to distribution records. The FDA does not have authority to compel companies to recall food products, such as peanuts. Source: www.fda.gov BPCA/Pediatric Exclusivity Statistics BPCA/Pediatric Exclusivity Statistics (updated) Source: www.fda.gov Sprout Recall Due to Potential Contamination with Listeria On April 9, 2009, Amalgamated Produce, Inc. announced that it is voluntarily recalling certain brands of sprouts due to potential contamination with Listeria monocytogenes, a foodborne pathogen that can cause serious illness and death. Source: www.fda.gov Generic Drug Petition Tracking: Suitability Tracking Reports Generic Drug Petition Tracking: Suitability Tracking Reports Source: www.fda.gov FDA Alerts the Public to Uncle Chen and Lian How Brand Expanded Recall The U.S. Food and Drug Administration (FDA) is alerting the public to the expanded, voluntary recall by Union International Food Company (Union City, Calif.) of sauces, oils, and oil blends sold under the Uncle Chen and Lian How brands. Source: www.fda.gov FDA Alerts the Public to Uncle Chen and Lian How Brand Dry Spice Product Recall The U.S. Food and Drug Administration (FDA) is alerting the public to a voluntary recall by Union International Food Company (Union City, Calif.) of the company's dry spice products. The recall is based on an investigation of an ongoing foodborne illness outbreak of Salmonella Rissen. This investigation is being conducted in collaboration with state health officials in California, Oregon, Nevada, Washington and the U.S. Centers for Disease Control and Prevention (CDC). The company's products are distributed in these states and Arizona. Source: www.fda.gov Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Source: www.fda.gov FDA Alerts the Public to Uncle Chen and Lian How Brand Expanded Recall The U.S. Food and Drug Administration (FDA) is alerting the public to the expanded, voluntary recall by Union International Food Company (Union City, Calif.) of sauces, oils, and oil blends sold under the Uncle Chen and Lian How brands. Source: www.fda.gov FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml Source: www.fda.gov CDER Organization Charts CDER Organization Charts (updated) Source: www.fda.gov Guidance for Industry Q10 Pharmaceutical Quality System Source: www.fda.gov FDA Serves Warrant for Inspection of Westco Fruit and Nuts Inc. At the request of the U.S. Food and Drug Administration, U.S. Marshals today executed an inspection warrant at Westco Fruit and Nuts Inc. (Westco/Westcott), an Irvington, N.J.-based company. Westco/Westcott did not provide access to distribution documents and declined to recall products after an FDA request. Regulated companies are required by law to grant FDA entry for inspection, as well as provide access to distribution records. The FDA does not have authority to compel companies to recall food products, such as peanuts. Source: www.fda.gov FDA Imposes Restrictions on Coast IRB due to Violations The U.S Food and Drug Administration today announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials. Source: www.fda.gov Guidance for Industry Newly Added Bioequivalence Recommendations Source: www.fda.gov Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection
See Web site for additional information Source: www.fda.gov April 20, 2009FDA: Insulin Pens and Insulin Cartridges Must Not Be Shared FDA: Insulin Pens and Insulin Cartridges Must Not Be Shared
The U.S. Food and Drug Administration today issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses. Source: www.fda.gov April 19, 2009Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers Drug Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers
The transition from albuterol CFC MDIs to albuterol HFA MDIs is now complete and supplies of albuterol HFA and levalbuterol HFA MDIs continue to meet total market demand. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin Please call 1-888-TevaUSA for additional information. Teva is manufacturing at full capacity. Bedford Customer Service 1-440-232-3320 Source: www.fda.gov FDA Imposes Restrictions on Coast IRB due to Violations The U.S Food and Drug Administration today announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials. Source: www.fda.gov FDA Alerts the Public to Uncle Chen and Lian How Brand Expanded Recall The U.S. Food and Drug Administration (FDA) is alerting the public to the expanded, voluntary recall by Union International Food Company (Union City, Calif.) of sauces, oils, and oil blends sold under the Uncle Chen and Lian How brands. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Related information section for posted letter Source: www.fda.gov Pistachio Recall Expanded On April 6, 2009, Setton Pistachio, Terra Bella, Calif., expanded its recall of pistachio products. Source: www.fda.gov FDA Clears Rapid Test for Avian Influenza A Virus in Humans The test, called AVantage A/H5N1 Flu Test, detects influenza A/H5N1 in throat or nose swabs collected from patients who have flu-like symptoms. The test identifies in less than 40 minutes a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. Previous tests cleared by the FDA to detect this influenza A virus subtype can take three or four hours to produce results. Source: www.fda.gov |
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