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| 麦克风 | 把脉FDA局长2018年全年计划和聚焦热点领域

By 月季 •  2018-01-06 14:01 •  6次点击 短消息

把脉FDA局长的2018年计划和聚焦热点领域


“鼓励更多的基因治疗(精准医学);重新制定和修改关于医疗器械和设备的审评规范和标准(更多智能化被引入和提高效率);倡导用科学膳食方法抵抗疾病。” 这是美国FDA局长刚刚接受访谈时透露的最新消息。


第九届中美临床与转化医学国际论坛的内容策划,在保持聚焦“精准医学和转化研究”核心内容的同时,我们已经把“倡导用科学膳食方法或功能饮食抵抗疾病” 作为今年2018年第九届中美国际论坛的亮点之一。


以下是FDA局长采访原文

麦克风:只传话、不翻译、原汁原味:


"We're going to announce in the next couple of weeks apolicy road map," Gottlieb said. “It’s going to lay out what our 2018 agenda's going to be, or at least a good part of it.”


Gottlieb, who was tapped by President Donald Trump to reform an agency the president had criticized as "slow and burdensome," has overseen a flurry of activity to speed up FDA, includin gapproving more than 1,000 generic drugs last year, a record.


One major focus in 2018: gene therapy, just months after FDA approved its first. "We think we're at an inflection point," Gottlieb said, adding that FDA will likely put out disease-specific guidance on how to develop gene-therapy products, how to define the endpoints and how to create accelerated approval pathways.


Another priority is a renewed focus on nutrition." It's going to be a comprehensive initiative," Gottlieb promised." We're going to look at how we can use tools of labeling of fooding redients as ways to help create better incentives for people to adopt better diets and for food producers to produce products that have more healthful attributes."


Gottlieb added the agency will ramp up food safety, particularly after a recent report that found some products recalled by the FDA were being left on the shelves for months, putting consumers at risk for poisoning. " One recall that isn't done appropriately or efficiently is one too many, so we take this very seriously," Gottlieb said. "We're going to look to provide more information around where you might have received a recalled product" and name the retailers, a departure from previous FDA practice.


The commissioner also touted a significant effort on" trying to facilitate access to biosimilars in the same way we did with small-molecule generic drugs." And he promised a "comprehensive framework" on modernizing medical device safety.


On the podcast, Gottlieb talked about the agency's growing role in regulating tobacco and its strategy to reduce smoking-related deaths. For instance, FDA is steadily advancing a proposed rule intended to make cigarettes non-addictive. The agency is also seeking to regulate flavors in tobacco products, including e-cigs, to make them less appealing to youth.


"Those are two of the bigger public health pieces," Gottlieb said, arguing that all aspects of FDA's tobacco cessation plan need to succeed because they're built to reinforce each other." This isn't a potluck approach to policy-making — this is anall-or-nothing approach."


The FDA commissioner also reflected on Puerto Rico's ongoing recovery from hurricanes that devastated the island last fall andcrippled its medical products sector. While the disaster exacerbated some medical shortages in the continental United States, Gottlieb mostly focused on his long-term concerns for the island. " The economic health of the island is dependent on medical products, and so we need to do what we can to help the island maintain the vibrancy of that sector."


The commissioner also discussed why he decided to take the job and how he prioritizes his work, given FDA's vast responsibilities. Ascommissioner, " you literally have a mini-crisis every day," Gottlieb said. " If you just focus your whole day on that … you're not going to move the policy agenda, and so you need to position yourself and staff yourself to be able to do both simultaneously."

是的、就是下周五1月12日,在北京

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