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Biotechnology Industry Organization - Prescription Drug User Fee Act
The mission of BIO is to be the champion of biotechnology and the advocate for its member organizations –both large and small. Here it gives information on regulatory program for pharmaceutical/biotechnology industry concerned with the approval time for New Drug Applications (NDA) and Biological License Applications (BLA).
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Center for Regulatory Effectiveness - Emerging Regulatory Issues
The mission of the CRE is to ensure that the public has access to data and information used to develop federal regulations, and to ensure that information which federal agencies disseminate to the public is of the highest quality. Here it keeps a record of all the federal regulations includind issues related to Drug Regulations.
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The Association of Clinical Research Organizations (ACRO) - Key Issues / Regulatory Issues
The mission of ACRO is to provide specialized services that are integral to the development of drugs, biologics, and medical devices. ACRO advances clinical outsourcing to improve the quality, efficiency, and safety of biomedical research. Here it gives informayion on ACRO's on-going coverage of Regulatory Issues in Drug Development.
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FDA/Center for Drug Evaluation and Research - Guidances & Enforcement Information
The mission of CDER is to assure that safe and effective drugs are available to the American people. Here it gives information on Regulatory & Scientific Guidances and legislation on drug products.
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The United States Pharmacopeia - Drug Quality Issues
The mission pf USP is to provide Quality assurance and objective drug information on the use of pharmaceuticals through partnerships and policy dialogue on global issues, and through regional and national initiatives. Here it gives information on quality of pharmaceuticals at global, national and regional levels.
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World Health Organization - Drug regulation
The mission of WHO is the attainment by all peoples of the highest possible level of health. Here it gives ingormation on various means to achieve Effective drug regulation.
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Médecins Sans Frontières (MSF) - Legal and Regulatory Issues Affecting Drug Development for Neglected Diseases
Médecins Sans Frontières (MSF) is an international humanitarian aid organisation with a mission to provide emergency medical assistance to populations in danger in more than 80 countries. Here it gives information on the Legal and Regulatory Issues Affecting Drug Development for Neglected Diseases and Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
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