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 Wysłany: Nie 12:01, 13 Mar 2011 Temat postu: Global Alliance proposal _1028 accessories |
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Global Alliance proposal materials
sCouncil) on the creation of the regional organization Over the years, IPEC, including three branches of the U.S. IPEC, IPEC Europe and Japan JPEC, known as TriPEC, 2008, China established the expansion of IPEC IPEC to provide opportunities, but also provides a medicinal materials quality, safety and function of the global debate platform. Chairman IPEC Europe PatriciaRafidison that the materials supply security-related public health disasters continue to hit the newspapers, IPEC initiatives and to promote quality than ever before, even more important, it is foreseeable that more countries or regions IPEC will be set up to ensure that the auxiliary problem is a global concern. IPEC Chairman JaneenSkutnik said the United States, the formation of IPEC IPEC alliance is an important step in the progress of organizations to ensure a complete supply chain needs of pharmaceutical materials joint,[link widoczny dla zalogowanych], global effort, the Union will contribute to the creation of IPEC global solution to the global problem. In recent years, IPEC has been looking to develop guidelines to implement the global materials, the further establishment of the alliance of these expectations into reality, to provide a consistent and coordinated accessories standard. PEC Director-General of Japan KeijiKijima said, IPEC alliance was set up to improve the quality of medicinal materials and to promote public health, from medical standard of full coordination and interchangeable accessories goes a step further. February 18 ~ 19, representatives from the IPEC conference in Los Angeles, the drafting of IPEC alliance responsibilities and vision. Planning decisions at the next meeting in Yokohama, Japan launched IPEC alliance. MktL2009, 36 (13) 15 (Zheng Xiaoqiong Abstract) approval of new drugs and new indications for dynamic 060 122 009 FDACDER in June the U.S. anti-infective Advisory Committee meeting schedule June 2, the Committee will discuss the company's cethromycin oral tablet AdvancedLifeSciences New Drug Application ( NDA22-398), the drug for the treatment of mild to moderate community-acquired pneumonia adult outpatients. June 3,[link widoczny dla zalogowanych], the Committee will discuss the development of tuberculosis (including drug-resistant TB) drug therapy problems discussed include diagnosis, treatment and study design (such as endpoints and follow-up period), and security issues. Psychopharmacology Drug Advisory Committee June 9 to 10 May, the Committee will discuss new drug application for the following safety and effectiveness. 1. AstraZeneca's Seroquel (quetiapine,[link widoczny dla zalogowanych], quetiapine) for young people aged 13 to 17 new drug applications for emergency treatment of schizophrenia (NDA20-639 / S a 045) and for children aged 10 to 12, and 13 Emergency treatment of bipolar mania young New Drug Application (NDA20-639 / S A 046); 2. Pfizer's Geodon (ziprasidone,[link widoczny dla zalogowanych], ziprasidone) for 10 to 17-year-old children and adolescents with or without psychotic features associated with bipolar affective disorder manic or mixed episodes of the emergency treatment of drug application ( NDA20-825 / S A 032); 3. EliLillyandCompany's Zyprexa (olanzapine,[link widoczny dla zalogowanych], olanzapine) for type I bipolar disorder associated with manic or mixed episodes of the emergency treatment of drug application (NDA20-592/S-040) and for adolescents with schizophrenia emergency treatment of drug application (NDA20-592 / S for a 041.) The Committee will vote on whether these products are effective and these pediatric indications, with acceptable safety. Arthritis Drugs Advisory Committee June 16, the Committee will discuss Savient pharmaceutical company Krystexxa (pegloticase) for the treatment of refractory gout biological license application (BLA125293). Ophthalmic Drugs Advisory Committee skin and June 2613, the Committee will discuss the company's 1.5 Ista Pharmaceutical Bepreve (bepotastinebesilate) ophthalmic solution for use with the treatment of allergic conjunctivitis, eye pruritus New Drug Application (NDA22-288), and biotechnology companies RiverPlate sodium hyaluronate 0.18 (sodiumhyaluronate) eye with a 7 '
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