FDA今年将对上市销售的未获批产品采取执法行动
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FDA今年将对上市销售的未获批产品采取执法行动
笔记 2014-01-12 Lachman CONSULTANTS 2014年:FDA开始对上市销售的未获批药品采取强有力的执法行动 2013年.几乎没有见到对上市销售的未获批药品采取执法行动,FDA将于2014年1月10日在“联邦公报”(FR)发布两份针对若干药品的强制措施的通告。 FDA将对某些未获批就上市销售硫酸可待因、磷酸可待因和二氢可待因的药品采取行动,这些药品含有未获批ANDA(Abbreviated New Drug Application,简化新药申请)或NDA(New Drug Application,新药申请)或完全符合适用的非处方药(OTC)专论(用于6岁及以上儿童的可待因止咳糖浆)的。预发布的FR通告请见此处 在一份单独的FR通告(请见此处
尽管上述许多药品不再上市销售,FDA仍指出“这些名录中认定的所有药品,或与名录中药品相同、相关、或类似的药品(简称为IRS产品, identical, related, or similar (IRS) product),不属于获批的NDA、ANDA(不同于符合适用OTC专论的非处方药品(OTC))的药品,自本通告生效之日起,以州际贸易的形式发货均为非法。” 随着2014年的这一开端,问题在于,在经历了处理未获批销售药品极度缓慢的一年之后,今年会成为具有持续性、确实采取执法行动和努力的一年,还是这一措施仅仅是针对2014年的权宜之计呢? 2014 Starts Out with a Strong Unapproved Drug Enforcement Action With little activity seen in 2013 in the enforcement arena for marketed unapproved drug products, FDA will publish two Federal Register (FR) notices on January 10, 2014 addressing enforcement action for a number of products. FDA will move against certain unapproved marketed codeine sulfate, codeine phosphate and dihydrocodeine containing products marketed without approved ANDAs or NDA or in full compliance with an appropriate OTC monograph (codeine cough syrup for children 6 years of age and older). The prepublication of the FR notice can be found here In a separate FR notice (here
While many of the above products are no longer being marketed, FDA notes that “[S]hipment in interstate commerce of any of the products identified in these dockets, or any identical, related, or similar (IRS) product to the products in these dockets, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph) is unlawful as of the effective date of this notice.” With this start to 2014, the question becomes will this be a year of sustained, substantial enforcement actions and efforts relative to unapproved marketed drug products after a very slow year or will this action be the exception rather than the rule for 2014. |