For Valentine’s Day, FDA issued a new guidance on metabolite safety testing. Essentially, it outlines the non-clinical testing that may be required when the metabolism in humans produces significantly higher amounts of the same metabolites in the animal species where the toxicology was assessed.
As the guidance points out, recent advances in analytical technology have revealed [...]
Archive for February, 2008
Metabolites: New safety testing requirements - impact on 505(b)(2)
Published February 15th, 2008 in 505(b)(2) Issues. 0 CommentsAnother “unapproved” drug needs a 505(b)(2) approval
Published February 7th, 2008 in News Commentary. 0 CommentsFDA is continuing to act on its promise made in January 2007 to remove products from the market that it considers unapproved. These products, some stemming from the DESI process, have been with us many years. The latest casualty is Colchicine for Injection. On February 6, FDA announced it was taking enforcement action because the [...]
A single Phase 3 trial needed for 505(b)(2) approval of a combination drug
Published February 7th, 2008 in 505(b)(2) Process and News Commentary. 0 CommentsAlchemia Ltd., an Australian pharmaceutical company, announced that it had gained agreement with FDA that a single Phase 3 trial would suffice for approval of its chemotherapeutic drug HA-irinotecan (a new drug containing irinotecan (Pfizer’s Camptosar®) formulated with hyaluronic acid (HA). Alchemia has conducted phase 1 and 2 studies outside the U.S. It presented the results [...]