The FDA has come down on the side of one of its divisions and will require Canada's Cipher Pharmaceuticals to mount a new trial in order to substantiate the safety of CIP-Isotretinoin for severe acne. Cipher had appealed the decision of the FDA's Division of Dermatology and Dental Products, saying that researchers had addressed the clinical question. Cipher says it's now reviewing the FDA's position to see how to best proceed.
- here's the release [1] on the FDA's decision
Related Article:
Tramadol-ER fails in latest Phase III trial. Report [2]
Links:
[1] http://www.fiercebiotech.com/press-releases/press-release-sciele-pharma-and-lifecycle-pharma-announce-fda-approval-new-formulatio
[2] http://www.fiercebiotech.com/story/tramadol-er-fails-in-latest-phase-iii-trial/2006-09-11