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Petition for stem cell policy change circulated; Stem cell research moving forward; FDA initiative seeks to speed up approvals.
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An expert advises how to best comply. Slipping away are the days of pen-and-paper record keeping. Here to stay are electronic records and electronic signatures.
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In a never-ending quest to make clinical trials safe for participants and learn from unfortunate incidents that may have occurred during a clinical trial, the Food and Drug Administration is not only scrutinizing corrective and preventive action plans (CAPA), but also looking outside of health care for effective quality assurance processes.
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Although progress is being made, advocates say, women still have a lot of catching up to do after decades of historical, cultural, and legal barriers that excluded them from both the benefits and risks of participation in medical research.
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FDA Rejects Plan B Bid; Rosuvastatin: Markets Most Potent Statin; FDA Actions
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The interaction of cell to cell negative with cell to cell positive may be the crucial consideration between real patients.
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The case for this PCR assay for aspergillus DNA remains unproven; and that proof can only be obtained by undertaking a formal prospective study in which samples for the detection of galactomannan and fungal DNA by PCR are taken at several predetermined intervals eg, 2-3 times weekly from all patients at risk.
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A fourth pathogen, Rickettsia parkeri, has been identified as a newly identified cause of rickettsial spotted fever in the United States.
