carcinogenicity

EFSA's panel on Food Additives and Nutrient Sources added to Food (ANS) was asked by the European Commission for its scientific opinion on the results of the long-term carcinogenicity study of rats that were exposed aspartame.

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Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at doses up to and including 900 mg/kg/day and

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Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Somaxon's business, including, without limitation, Somaxon's interpretation of its communications and interactions with the FDA relating to the requirements for approval of the NDA for Silenor, and the FDA's agreement with such interpretation; Somaxon's interpretation of the results of the clinical trials for Silenor, the timing of the interpretation of such results and the FDA's agreement with such interpretation; the potential for Somaxon to make a resubmission to the Silenor NDA; the potential for Silenor to receive regulatory approval for one or more indications on a timely basis or at all; the potential for the FDA to impose non-clinical, clinical or other requirements to be completed before or after regulatory approval of Silenor; Somaxon's ability to demonstrate to the satisfaction of the FDA that potential NDA approval of Silenor is appropriate prior to the completion of standard, long-term carcinogenicity studies, given the context of completed trials and pending studies; the timing and results of non-clinical studies for Silenor, and the FDA's agreement with Somaxon's interpretation of such results;

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This required a method any case, one Company, supposedly laudibly, to establish carcinogenicity, which is now an impor - searched for a nonalcoholic solution for their sulfo - tant element in the toxicology package for an over - namide.

Recently Uploaded Slideshows martins0105 2009

Dr. Hamburg's dismissal of standard carcinogenicity tests is bizarre.

Samuel S. Epstein: Multiple Carcinogens in Johnson & Johnson's Baby Shampoo Samuel S. Epstein 2011

Dr. Hamburg's dismissal of standard carcinogenicity tests is bizarre.

Samuel S. Epstein: Multiple Carcinogens in Johnson & Johnson's Baby Shampoo Samuel S. Epstein 2011

As published in the Feb. 25, 2011 Science Insider editorial, "Advancing Regulatory Science," FDA Commissioner Dr. Hamburg claimed that FDA's regulations must be based on "better predictive models -- functional genomics, proteomics, and metabolomics," rather than "high dose animal carcinogenicity studies -- unchanged for decades."

Samuel S. Epstein: Multiple Carcinogens in Johnson & Johnson's Baby Shampoo Samuel S. Epstein 2011

Dr. Hamburg's dismissal of standard carcinogenicity tests is bizarre.

Samuel S. Epstein: Multiple Carcinogens in Johnson & Johnson's Baby Shampoo Samuel S. Epstein 2011

Dr. Hamburg's dismissal of standard carcinogenicity tests is bizarre.

Samuel S. Epstein: Multiple Carcinogens in Johnson & Johnson's Baby Shampoo Samuel S. Epstein 2011

As published in the Feb. 25, 2011 Science Insider editorial, "Advancing Regulatory Science," FDA Commissioner Dr. Hamburg claimed that FDA's regulations must be based on "better predictive models -- functional genomics, proteomics, and metabolomics," rather than "high dose animal carcinogenicity studies -- unchanged for decades."

Samuel S. Epstein: Multiple Carcinogens in Johnson & Johnson's Baby Shampoo Samuel S. Epstein 2011