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submissions to safeguard the proprietary information in such submissions and to assure that the administrative record is complete. The same procedures also apply to contacts with ... (Abstract truncated to see more please, go to the document!) USA - SOPP 8401: Administrative Processing of Biologics License Application (BLA), 01-May-2007 This document provides policies and procedures to Center for Biologics Evaluation and Research (CBER) staff on the administrative processing of the Biologics License Application (BLA). USA - Thomas P. Gross, M.D. (Midlands Orthopaedic Group LLC) , 21-Jun-01-Jul- 2005: EIR, FDA 483 and Correspondence This inspection was conducted in accordance with Compliance Program 7348.811 (Clinical Investigators). The assignment requested a full data audit to determine the investigator's compliance with the signed investigator agreement and to FDA regulations. Seven deficiencies were reported on a form FDA 483 at the conclusion of the investigation. A warning ... (Abstract truncated to see more please, go to the document!) USA - Untitled Letter: KV Pharmaceutical Company, 17-May-2007 This untitled letter was sent by FDA's DDMAC (Division of Drug Marketing, Advertising and Promotion) to KV Pharmaceutical Company to request the removal of violative promotional material, specifically an e-Pharm/alert e-mail sent by the firm under cover of form FDA 2253 for Clindesse (clindamycin phosphate). The e-Pharm/alert e-mail is false or misleading ... (Abstract truncated to see more please, go to the document!) USA - Vaccines and Related Biological Products Advisory Committee (Briefing Information): Safety and Immunogenicity of a Live Vaccinia Virus Smallpox Vaccine (ACAM2000) Manufactured by Acambis, Inc. 17-May-2007 The Vaccines and Related Biological Products Advisory Committee (63148) voted unanimously that the safety and efficacy data for ACAM2000 (live vaccinia virus smallpox vaccine) was sufficient to support the use of the vaccine in high-risk situations. The committee was also generally positive about the proposed Risk Minimization Action Plan (RiskMAP). ... (Abstract truncated to see more please, go to the document!) USA - Warning Letter: Allergan, Inc., 25-May-2007 This warning letter was sent by FDA's DDMAC (Division of Drug Marketing, Advertising and Communications) to Allergan Inc. (Irvine, California) to request the removal of violative promotional material, specifically a professional journal advertisement for Acular LS (ketorolac tromethamine ophthalmic solution) submitted by the firm under cover of form ... (Abstract truncated to see more please, go to the document!) USA - Warning Letter: Davol, Inc., Sub C.R. Bard, Inc., 24-Apr-2007 An inspection of CR Bard's subsidiary Davol, Inc. in Cranston, Rhode Island revealed that the medical devices manufactured by this firm (Composix Kugel Hernia Patches and Salute Fixation devices) were adulterated as a result of significant deviations from the Quality System regulations as defined in 21 CFR Part 820. Five deviations are reviewed in this warning letter. USA - Warning Letter: Enzon Pharmaceuticals, Inc., 21-May-2007 This warning letter was sent by FDA's DDMAC (Division of Drug Marketing, Advertising and Communications) to Enzon Pharmaceuticals, Inc. to request the removal of violative promotional material, specifically a flash card submitted by the firm under cover of form FDA 2253 for Abelcet (Amphotericin B Lipid Complex Injection). The flash card is misleading
... (Abstract truncated to see more please, go to the document!) USA - Warning Letter: MedImmune, Inc., 24-May-2007 An inspection of MedImmune U.K. Ltd, Medimmune Inc.'s subsidiary in Liverpool, UK, revealed significant deviations from current good manufacturing practice in the manufacture of FluMist bulk monovalent lots used to manufacture Influenza Virus Vaccine Live, Intranasal. Specific areas of concern include: investigation of bioburden excursions, production ... (Abstract truncated to see more please, go to the document!) EPARs European Union - EMEA EPAR CHMP/65656/04 Rev 4: RAPTIVA (efalizumab), APR-2007 - Name of the medicinal product: RAPTIVA - International Nonproprietary Name (INN): efalizumab - Applicant: Serono Europe Limited - Indications: RAPTIVA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to or who have a contraindication to or are intolerant of other systemic therapies including cyclosporin, methotrexate ... (Abstract truncated, to see more please, go to the document) European Union - EMEA EPAR EMEA/H/C/0113 Rev 22: INVIRASE (saquinavir), MAY-2007 - Name of the medicinal product: INVIRASE - Marketing Authorisation Holder: Roche Registration Limited. - International Nonproprietary Name: Saquinavir - Pharmacotherapeutic group (ATC Code): Antiviral agent (J05A E01) - Therapeutic indication: Invirase is indicated for the treatment of HIV-1 infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral ... (Abstract truncated, to see more please, go to the document) European Union - EMEA EPAR EMEA/H/C/0128 Rev 18: CRIXIVAN (indinavir), MAY-2007 - Name of the medicinal product: CRIXIVAN - Marketing Authorisation Holder: Merck Sharp & Dohme Limited - International Nonproprietary Name: Indinavir - Pharmaco-therapeutic group - (ATC Code): Antiviral agent - (J05A E02) - Therapeutic indication: CRIXIVAN is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults, adolescents, and children ... (Abstract truncated, to see more please, go to the document) European Union - EMEA EPAR EMEA/H/C/0165 Rev 12: MABTHERA (rituximab), APR-2007 - Name of the medicinal product: MABTHERA - International Nonproprietary Name: rituximab - Marketing Authorisation Holder: Roche Registration Limited - Pharmacotherapeutic group (ATC Code): Antineoplastic Agents, Monoclonal antibodies (L01XC02) - Therapeutic indication: MabThera is indicated for treatment of patients with stage III-IV follicular lymphoma who are chromoresistant or are in ... (Abstract truncated, to see more please, go to the document) European Union - EMEA EPAR EMEA/H/C/0363 Rev 8: KINERET (anakinra), MAY- 2007 - Name of the medicinal product: KINERET - International Nonproprietary Name: Anakinra - Marketing Authorisation Holder: Amgen Europe B.V - Pharmaco-therapeutic group (ATC code): Immunomodulator - (L04AA14) - Therapeutic indications: Treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that
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