MEDWatch: the new FDA medical products reporting program.
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Biomedical subjects
Publications and source records attributed to D A Kessler.
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Prescription drug advertising has been regulated by the Food and Drug Administration since 1962. In the past decade, pharmaceutical companies have employed new communication mechanisms to reach physicians and, with increasing frequency, consumers. Examples of physician-oriented promotional activities are medical symposia and teleconferences. Consumer-oriented efforts include press conferences, use of celebrity spokespeople, and direct-to-consumer advertising. The Food and Drug Administration has asserted its legal jurisdiction over these nontraditional promotional activities and is regulating them on a case-by-case basis. As nontraditional promotional efforts become more prevalent, the Food and Drug Administration's regulatory framework must be able to meet the challenges of a changing environment.
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There is increasing recognition that federal food safety laws and policies need to be revised. Congressional debate on proposed amendments to the Food, Drug, and Cosmetic Act has generated several different perspectives on how the food safety laws should be changed. Before a consensus can be reached, scientists, regulators, the food industry, and consumers will have to review such complex and controversial issues as the level of acceptable risk, the value of risk-benefit analysis, the proper role of independent scientific review, and the reliability of quantitative risk assessment.
Tumor angiogenesis factor (TAF) elicits a strong vasoproliferative response when implanted upon the chorioallantoic membrane (CAM) of the chick embryo. This response is first observed stereomicroscopically 2-3 days after implantation. A 40-fold increase in mast cell density is observed within the vicinity of this implant by 24 h. Mast cells that have been isolated from retired breeder Sprague-Dawley rats fail to evoke a vascular reaction when implanted on the CAM. An intermediate role for the mast cell in tumor angiogenesis is suggested.
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The authors investigated the potential role the fibrin sealant system may portray in the fixation of osseous implants. The application of a layer of fibrin did not interfere with the fixation of osseous implants of either pyrolytic carbon or Biolite-coated porous titanium. A greater percentage of tissue ingrowth was observed in the porous titanium implants in the presence of the fibrin sealant system; however, no significant difference in the ultimate interfacial shear stress was observed.