2010年3月11日星期四
On 10 and 11 March 2010, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) – including the Pulmonary-Allergy Drugs and the Drug Safety and Risk Management Advisory Committees – discussed the design of post-marketing safety studies for long-acting beta-agonist (LABA)-containing products in the U.S., including SYMBICORT (budesonide/formoterol fumarate dihydrate).
“As we’ve witnessed over the past two days, there are many challenges in designing and executing a relevant, feasible and ethical post-marketing safety study that answers FDA’s question regarding LABA-containing products,” said Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca. “AstraZeneca is confident in the positive benefit-risk profile of SYMBICORT in asthma as demonstrated by extensive clinical data and patient experience, and supports ongoing scientific discussion to address any outstanding questions regarding the use of combination LABA and inhaled corticosteroid products for the treatment of asthma. We look forward to working with the FDA to execute a study design that is both scientifically robust and offers a pragmatic approach to answer critical questions regarding the appropriate use of LABAs.”
FDA经常召开咨询委员会会议，以获得关于临床事项的独立专家指导和建议。虽然FDA不需要遵循这一指导，但原子能机构通常会在关于公共卫生事项的决定时考虑到建议。
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