From the FDA's website:
>>DATE AND TIME: September 25, 26, and 27, 8:00 a.m.
LOCATION: Hilton, The Ballroom, 8727 Colesville Rd., Silver Spring, MD.
CONTACT: Kathleen Reedy or LaNise Giles, Center for Drug Evaluation and Research, 301-827-7001. On September 25, the committee will discuss appropriate designs for clinical trials of new osteoporosis treatments. On September 26, the committee will discuss the safety and efficacy of biologic licensing application BL 103979, FABRAZYME (agalsidase beta, Genzyme Corp.) for the treatment of Fabry's Disease. On September 27, the committee will discuss the safety and efficacy of biologic licensing application BL 103977, REPLAGAL (agalsidase alfa, Transkaryotic Therapies) for the treatment of Fabry's disease.<<
Cheers, Tuck |
