Orphan Drugs: FDA Advisory Committee Meetings (January – February 2014)
Biotechnology stock movements are affected at various phases of the FDA’s drug approval process. Big stock moves, either up or down, are associated with several catalysts :
• Releases of trial data
• Briefing documents prior to Advisory Committee meetings (AdComs)
• AdComs themselves
• Prescription Drug User Fee Act (PDUFA) dates.
The following chart identifies upcoming FDA Advisory Committee Meetings for the first two months of 2014.
FDA Advisory Committee Meetings (January – February 2014)
|Generic Name||Trade Name||Sponsor||Indication||2014 AdCom Date|
|Droxidopa||Northera||Chelsea Therapeutics||Symptomatic Neurogenic Orthostatic Hypotension For Patients With Primary Autonomic Failure||01/14/14|
Please note the links for the following 2 chart columns above :
1) “Indication” Column Link = Is the FDA Orphan Drug Product Designation Database Link
2) “2013 AdCom Date” = Is the FDA Advisory Committee Meeting Information.
Cellular, Tissue, and Gene Therapies Advisory Committee Meeting: 02/25–02/26/14
The Committee will discuss the following topics :
• Oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment infertility
• Guidance documents issued from Office of Cellular, Tissue, & Gene Therapies, Center for Biologics Evaluation and Research (CBER), FDA
• Considerations for design of early-phase clinical trials of cellular & gene therapy products.
Please Note: FDA Official Logo from FDA website.