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USA - Federal Register: Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Availability (Notice), 16-May-2007 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.’’ (70060) This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in new drug ... (Abstract truncated to see more please, go to the document!) USA - Federal Register: Science Board to the Food and Drug Administration; Notice of Meeting (Notice), 21-May-2007 This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). Date and Time: The meeting will be held on June 14, 2007, from 8 a.m. to 4 p.m. USA - Federal Register:Determination of Regulatory Review Periods for Purposes of Patent Extension; SPRYCEL - New Drug Applications 21-986 and 22-072 (Notice), 25-May-2007 The Food and Drug Administration (FDA) has determined the regulatory review period for SPRYCEL—new drug applications (NDAs) 21–986 and 22–072 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, ... (Abstract truncated to see more please, go to the document!) USA - GAO Testimony: Pediatric Drug Research: The Study and Labeling of Drugs for Pediatric Use under the Best Pharmaceuticals for Children Act, (GAO-07-898T), 22-May-2007 This testimony, provided by Marcia Crosse, Director, Health Care at GAO, is based on GAO Report GAO-07-557 (70061). GAO assessed (1) the extent to which pediatric drug studies were being conducted under BPCA for on-patent drugs, (2) the extent to which pediatric drug studies were being conducted under BPCA for off-patent drugs, and (3) the impact ... (Abstract truncated to see more please, go to the document!) USA - Heartland Repack Services LLC, 27-Jun-11-Aug-2006: FDA 483 and Correspondence This form FDA 483 was issued at the conclusion of an inspection of drug repacker Heartland Repack Services in Toledo, Ohio. 23 observations were reported by the FDA investigators. A warning letter was subsequently sent to the firm (63614). USA - Hospira, Inc., 23-Sep-11-Oct-2005: EIR This inspection, conducted in accordance with Compliance Program 7356.002 (Drug Manufacturing Inspections), was performed as a follow up to information collected in a previous inspection which indicated marketed drug products did not have completed process validation. No form FDA 483 was issued at the conclusion of the inspection. USA - Huntingdon Life Sciences, Inc., 25-Apr-06-May-2005: EIR, FDA 483 and Correspondence This inspection was conducted in accordance with Compliance Program 7348.808 (Good Laboratory Practice (Nonclinical Laboratories)). Inspectional coverage was given to management & study director responsibilities; personnel qualifications & training; standard operating procedures; vivarium; test article characterization, preparation, storage and dosing; ... (Abstract truncated to see more please, go to the document!)
USA - Impact Report: EMEA Meets Performance Goals, But Lags U.S. FDA in Drug Approvals: EMEA-FDA Goal to Offer Parallel Scientific Advice Likely to Aid Developers, Feb-2007 Main points in this January/February 2007 report are: - Mean approval times for 71 new medicinal products approved in the European Union (EU) by the European Medicines Agency (EMEA) through its centralized procedure and in the United States by the Food and Drug Administration (FDA) during 2000-05 were nearly identical (15.8 months vs. 15.7 months). - ... (Abstract truncated to see more please, go to the document!) USA - Letter: EXJADE (deferasirox) - Novartis, 14-May-2007 This letter from Novartis informs health professionals of the changes brought to the Warnings and Adverse Events sections of EXJADE (deferasirox)'s prescribing information, providing information on postmarketing reports of acute renal failure and cytopenias. It provides detailed safety information and recommendations for monitoring of patients. USA - Medwatch Safety Alert: AVANDIA (rosiglitazone), 21-May-2007 This document informs health professionals of an ongoing analysis of safety data from various types of clinical trials related to AVANDIA (rosiglitazone), an antidiabetic agent. As they show different rates of heart attack or heart-related adverse events, the potential cardiac risk remains uncertain. USA - Medwatch Safety Alert: Caffeine Citrated, Powder, Purified, 21-May-2007 This document informs health professionals of the recall by Spectrum of three lots of Caffeine Citrated, Powder, Purified, a cerebral and respiratory stimulant treating apnea in premature babies. This product may be subpotent, inducing lower blood levels of caffeine and a risk of respiratory depression. Health professionals are advised against compounding with this product. USA - Medwatch Safety Alert: EXJADE (deferasirox) Tablets for Oral Suspension, 22-May-2007 This document informs health professionals of labeling changes made by Novartis for EXJADE (deferasirox), indicated for the treatment of chronic iron overload due to blood transfusion. The Warnings and Adverse Reactions sections have been updated to include information on postmarketing reports of acute renal failure and cytopenias, including agranulocytosis, ... (Abstract truncated to see more please, go to the document!) USA - Medwatch Safety Alert: Integra LifeSciences ENDURA No-React Dural Substitute, 25-May-2007 The FDA informs of the recall by Integra LifeSciences, classified as class I on May 18, 2007, of all Shelhigh's ENDURA No-React Dural Substitute products distributed by Integra since 2003. This recall comes after the publication of the April 18, 2007 FDA Preliminary Public Health Notification (65159) requesting the recall of medical devices manufactured ... (Abstract truncated to see more please, go to the document!) USA - Medwatch Safety Alert: Unapproved Guaifenesin Timed-Release Drug Products, 25-May-2007 The FDA informs about its request that companies marketing unapproved guaifenesin products in timed-release form, often described as extended-release, long-acting or sustained-release medicines, should stop manufacturing and marketing these products, which are used to relieve cough and cold symptoms. The only FDA-approved timed-release guaifenesin ... (Abstract truncated to see more please, go to the document!)
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