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正當是西方的圣誕之際,在FDA官網(wǎng)出現(xiàn)《FDA Lapse in Funding》,從2018年12月22日開始，在沒有2019財政年度撥款或?qū)DA持續(xù)決議的情況下，F(xiàn)DA再次出現(xiàn)了停擺。這說明FDA出現(xiàn)了財政危機，除了部分緊急、對公共衛(wèi)生安全造成威脅的事宜，其它工作都已處在停滯狀態(tài)。

這已經(jīng)不是FDA的第一次停擺，至目前為止，停擺時間最長的一次為21天。由于此次停擺恰逢圣誕節(jié)日，F(xiàn)DA工作組已停止工作，我們卓遠天成也證實目前FDA審核員已經(jīng)不回復郵件，不反饋，不回應。截止現(xiàn)在，F(xiàn)DA還沒有正式出文說明是否會延長整改遞交或是工廠審查期限，所以各企業(yè)還是應當在規(guī)定的時限內(nèi)向FDA遞交補充材料，并積極做準備工作。一旦FDA恢復工作，各企業(yè)能迅速做出各項決定，盡可能降低對市場準入進度的影響。

FDA官網(wǎng)全文：

In the absence of either an FY 2019 appropriation or a Continuing Resolution for FDA, beginning on December 22, 2018 and  continuing until the date of enactment of an FY 2019 appropriation or Continuing Resolution ("lapse period"), agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety 

of human life and activities funded by carryover user fee funds.

The FDA plays a critical public health role. Our work protects the food that families feed their children and pets and ensures the effectiveness of the medicine they need, all of which contribute to improving the health and welfare of Americans. All our work is important, but only some of our work is permitted to continue during a lapse in funding.

During the lapse period, the agency will be continuing vital activities, to the extent permitted by the law, that are critical to ensuring public health and safety in the United States. The mission critical, public health activities that will continue include, among other things: maintaining core functions to handle and respond to emergencies – such as monitoring for and quickly  responding to outbreaks related to foodborne illness and the flu, supporting high-risk food and medical product recalls when products endanger consumers and patients, pursuing civil investigations when we believe public health is imminently at risk and pursuing criminal investigations, screening the food and medical products that are imported to the U.S. to protect consu-mers and patients from harmful products, and addressing other critical public health issues that involve imminent threats to the safety of human life. Mission critical surveillance for significant safety concerns with medical devices and other medical products will also continue.

In addition, the FDA will continue to support activities funded by carryover user fee balances, which allows us to continue to bring new therapeutic options to the patients that need them. However, during the lapse period, the FDA will not havelegal authority to accept user fees assessed for FY 2019 until an FY 2019 appropriation or Continuing Resolution for the FDA is enacted. This will mean that the FDA will not be able to accept any regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse period.