FDAnews starts "Genomics Newswire" and "Part 11 Compliance Report".Information publisher FDAnews (Falls Church Falls Church, independent city (1990 pop. 9,578), NE Va., a residential suburb of Washington, D.C.; inc. as a town 1875, as a city 1948. There is diverse light manufacturing, including telecommunications equipment. , VA) has begun the publication of two new titles, including Part 11 Compliance Report, a newsletter published 24 times a year, and Genomics Newswire, a weekly online report. An annual subscription costs $627 for the former and $595 for the latter. Subscribers to Part 11 also receive the FDAnews Daily Bulletin. Part 11 focuses on the issues surrounding compliance with 2lCFR Part 11, the FDA's regulation for electronic records and electronic signitures. The regulation stipulates how companies create, validate, store, access and change computerized computerized adapted for analysis, storage and retrieval on a computer. computerized axial tomography see computed tomography. records. It includes information on forthcoming guidance documents, best practices, case studies, reports on enforcement activity, and interviews. Genomics Newswire carries news and analysis involving the genomics industry, including emerging issues, new therapies in clinical trials, diagnostics, therapeutic cloning therapeutic cloning n. A procedure in which damaged tissues or organs are repaired or replaced with genetically identical cells that originate from undifferentiated stem cells. and stem cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. research, drug discovery, ag biotechnology, and pharmacogenomics Pharmacogenomics is the branch of pharmacology which deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with a drug's efficacy or toxicity. . FDAnews also produces Washington Drug Letter, Generic Line, Devices & Diagnostics Letter and the Regulatory Watchdog Service. |
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