Christopher Exley, Louise Swarbrick, Rhomain K. Gherardi, and Francois-Jérôme Arthier Summary: Macrophagic myofasciitis and chronic fatigue syndrome are severely disabling conditions which may be caused by adverse reactions to aluminium-containing adjuvants in vaccines. While a little is known of disease aetiology both conditions are characterised by an aberrant immune response, have a number of prominent […]
The immunobiology of aluminium adjuvants: how do they really work?
Christopher Exley, Peter Siesjö, and Håkan Eriksson ABSTRACT: Aluminium adjuvants potentiate the immune response, thereby ensuring the potency and efficacy of typically sparingly available antigen. Their concomitant critical mportance in mass vaccination programmes may have prompted recent intense interest in understanding how they work and their safety. Progress in these areas is stymied, however, by […]
Fast-Tracking Oncology Drugs Questioned
MedPage Today By Kristina Fiore, Staff Writer, MedPage Today Published: March 27, 2011 Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner Cancer drugs rushed to the market via the FDA’s accelerated approval process often languish in confirmatory trials, agency researchers say. Out […]
Surveillance after treatment for cervical intraepithelial neoplasia: outcomes, costs, and cost-effectiveness.
Melnikow J, Kulasingam S, Slee C, Helms LJ, Kuppermann M, Birch S, McGahan CE, Coldman A, Chan BK, Sawaya GF. Department of Economics, Center for Healthcare Policy and Research, University of California, Davis, California 95817, USA. jamelnikow@ucdavis.edu Abstract OBJECTIVE: To estimate outcomes and costs of surveillance strategies after treatment for high-grade cervical intraepithelial neoplasia (CIN). […]
Accelerated Approval of Oncology Products: The Food and Drug Administration ExperienceAccelerated Approval of Oncology Products: The Food and Drug Administration Experience
John R. Johnson, Yang-Min Ning, Ann Farrell, Robert Justice, Patricia Keegan and Richard Pazdur Abstract We reviewed the regulatory history of the accelerated approval process and the US Food and Drug Administration (FDA) experience with accelerated approval of oncology products from its initiation in December 11, 1992, to July 1, 2010. The accelerated approval regulations […]
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