Celprogen Inc. has announced that they have successfully validated an in vivo model system for testing efficacy of cancer drugs and also novel drug candidates for Human Glioblastoma. This in vivo model system has been validated within United States research facilities for testing novel drug candidates against Human Glioblastoma. Celprogen’s in vivo model system would
Full Post: Celprogen introduces in vivo model for human glioblastoma
Caraco Pharmaceutical Laboratories, Ltd. announced today that it has timely submitted its response to the FDA warning letter that was received on October 31, 2008.
In the warning letter, the FDA requested a response from Caraco within 15 business days, ending November 24, 2008.
As previously disclosed, the warning letter was issued as a follow up to the last FDA inspection of the Company’s manufacturing facility in Detroit, Michigan which was initiated in May 2008. Until the Company’s responses to the observations have been clarified and explanations provided to the satisfaction of the FDA, the FDA may in the near term withhold approval of pending new drug applications listing the facility as the manufacturer. The Company’s sales of current products continue in the normal course of business.
The Company is committed to working cooperatively and expeditiously with the FDA to resolve the matters indicated in its letter. The Company has requested a meeting with the FDA as a follow up to its response. Caraco believes it has addressed the concerns in the warning letter appropriately.
http://www.caraco.com/
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