As readers of this blog will know, a 505(b)(2) application is a US NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Under the right circumstances, either a new chemical entity [...]
Archive for November 4th, 2009
Does Europe have a pathway for approval of drugs analogous to the FDA’s 505(b)2 pathway?
Published November 4th, 2009 in 505(b)(2) Process and How to:. 0 CommentsA New Paradigm for the Development of Drugs for Type 2 Diabetes
Published November 4th, 2009 in 505(b)(2) Issues and How to:. 0 CommentsDue to Camargo’s on-going client projects in this area, our chief medical officer, Dr. Sam Kaba recently attended a DIA-sponsored conference in Washington, D.C. entitled Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications: Current State of the Art and Opportunities to Advance the Science. His report:
The FDA Guidance for Industry on Evaluating Cardiovascular [...]
GTx Needs a 2nd Phase III Trial and more safety data
Published November 4th, 2009 in News Commentary. 0 CommentsGTx announced 11/2/2009 that it has received a Complete Response Letter from the FDA concerning its NDA for TOREMIFENE CITRATE 80 mg (ACAPODENE®). The NDA, filed in late December 2008, sought approval for use of toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT). The NDA was based on [...]