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Industry Resources
FDA - Food and Drug Administration - Responsible for approving food and drugs for widespread use.
Pharmasug - Pharmaceutical Industry SAS® User Group - Organization of professionals worldwide in the pharmaceutical industry who use SAS software in their work
ASA - American Statistical Association - Founded in 1839, ASA is the nation's leading professional association for statistics and statisticians.
DIA - Drug Information Association - With more than 27,000 members worldwide, the Drug Information Association (DIA) is the premier member-driven organization encompassing the full continuum of disciplines in the pharmaceutical and related industries.
Biospace - A biotechnology website with links to science articles and company information.
CDISC - Clinical Data Interchange Standards Consortium - An open, multidisciplinary, non-profit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in our industry.
ICH - The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
ebla.pdf - REVISED Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA) / Establishment License Application (ELA) and New Drug Application (NDA)] - 11/12/1999, REVISED 11/22/1999
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