The FDA has approved a new drug for treating diabetes.
FDA已经批准了一种新的糖尿病治疗药物。
The FDA sets standards for food safety in the United States.
FDA为美国的食品安全设定了标准。
The company recalled its product after the FDA raised concerns about its safety.
在FDA对产品的安全性提出担忧后，该公司召回了其产品。
The FDA is responsible for regulating cosmetics as well as drugs.
FDA负责化妆品以及药品的监管。
The FDA conducts regular inspections to ensure compliance with regulations.
FDA进行定期检查以确保遵守规定。
The approval process for a new vaccine by the FDA can take years.
FDA对新疫苗的审批过程可能需要数年。
The FDA issued a warning about the potential side effects of the medication.
FDA发布了关于该药物可能的副作用的警告。
The FDA requires clinical trials before approving a new treatment.
FDA在批准新的治疗方法前需要进行临床试验。
The agency is part of the U.S. Department of Health and Human Services and is commonly known as the FDA.
该机构是美国卫生与公众服务部的一部分，通常被称为FDA。
The FDA's main goal is to protect public health by ensuring the safety and efficacy of products.
FDA的主要目标是通过确保产品安全和有效来保护公共卫生。
Many regulatory authorities in Southeast Asia rely on the FDA results, and the application process is more about completing the registration process.
东南亚的许多监管机构都依赖于美国食品药品监督管理局的结果，申请过程更多的是完成注册过程。
"In addition, obtaining high-quality endorsements from the FDA will also greatly assist in accelerating the approval of more indications of the product, especially in Southeast Asian countries where companies can accept applications for indications already listed in China," Li said.
李说：“此外，获得美国食品药品监督管理局的高质量背书也将大大有助于加快该产品更多适应症的审批，特别是在东南亚国家，这些国家的公司可以接受已经在中国上市的适应症申请。”。
In an online media conference on Monday, Yao Sheng, senior vice-president of Junshi Biosciences, said the company had signed cooperation agreements with foreign partners including Coherus, Hikma, Rxilient Biotech and Dr. Reddy's that cover more than 50 markets, and expects the drug to get greater presence worldwide following the approval from the US FDA.
在周一的一次在线媒体会议上，君实生物高级副总裁姚胜表示，该公司已与包括Cohereus、Hikma、Rxilient Biotech和Dr.Reddy’s在内的外国合作伙伴签署了涵盖50多个市场的合作协议，并预计该药物在获得美国食品药品监督管理局批准后将在全球范围内获得更大的影响力。
The Chinese biotech and its US partner Coherus BioSciences Inc jointly announced on Oct 27 that the US FDA approved Loqtorzi (toripalimab-tpzi) in combination with other drugs for the first-line treatment of adults with metastatic or recurrent locally advanced metastatic nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
10月27日，中国生物技术公司及其美国合作伙伴Cohereus BioSciences Inc联合宣布，美国FDA批准Loqtorzi（托帕利单抗-tpzi）与其他药物联合用于成人转移性或复发性局部晚期转移性鼻咽癌（NPC）的一线治疗，或在含铂化疗时或之后具有疾病进展的转移性NPC。
The FDA has authorized the temporary importation of cisplatin from China in an effort to ease an acute shortage of cancer drugs in the US, according to an update posted to the agency's website.
根据FDA网站上发布的最新消息，FDA已授权从中国临时进口顺铂，以缓解美国癌症药物的严重短缺。
The cisplatin injections from Qilu are marketed and manufactured in China and are not FDA-approved", according to the FDA statement.
根据美国食品药品监督管理局的声明，齐鲁的顺铂注射液在中国销售和生产，未经美国食品药品管理局批准”。
Qilu said in a statement on its official WeChat account that it received an urgent email from the FDA in March, calling for cisplatin supply amid US drug shortages.
齐鲁制药在其官方微信账号上的一份声明中表示，它在3月份收到了美国食品药品监督管理局的一封紧急电子邮件，呼吁在美国药品短缺的情况下供应顺铂。
Soon after, the FDA launched a quick approval process.
不久之后，美国食品药品监督管理局启动了快速审批程序。
It is also the only veterinary drug approved by the FDA to treat and prevent gastric ulcer in the United States.
它也是美国唯一一种被美国食品药品监督管理局批准用于治疗和预防胃溃疡的兽药。
The US Food and Drug Administration (FDA) recently launched an investigation into the baby formulas following complaints of Cronobacter sakazakii and Salmonella Newport infections, said the General Administration of Customs (GAC), citing an FDA announcement.
美国海关总署（GAC）援引美国食品药品监督管理局（FDA）的一份公告称，在收到关于阪崎克罗诺杆菌和纽波特沙门氏菌感染的投诉后，美国食品和药物管理局最近对这些婴儿配方奶粉展开了调查。
The GAC said it will continue to closely follow the FDA's investigation on the matter and keep consumers updated of any progress.
GAC表示，将继续密切关注美国食品药品监督管理局对此事的调查，并随时向消费者通报最新进展。
The therapy, which was approved by the FDA on Friday, was a breakthrough after years of research and will bring novel treatment solutions for patients, especially those with drug-resistant or refractory conditions and those prone to develop into severe cases.
该疗法于周五获得美国食品药品监督管理局的批准，是经过多年研究后的一项突破，将为患者带来新的治疗方案，尤其是那些具有耐药性或难治性疾病的患者以及那些容易发展为重症的患者。
Visitors are likely to be drawn by the first oral antiviral medicine against COVID-19 if and when it's approved by FDA.
如果美国食品和药物管理局(FDA)批准首款抗新冠病毒口服药物，这一动向很可能吸引许多民众的关注。
The orally taken drug has been granted orphan drug and fast track designation by the US FDA.
该口服药物已获得美国食品药品监督管理局(FDA)的孤儿药和快速通道指定。
Last year, Ascentage obtained 10 orphan drug qualifications from the US FDA, becoming the enterprise with the largest number of such qualifications in the world that year.
去年，亚盛医药共获得10项美国FDA孤儿药资格认定，成为当年全球获得该认定数量最多的企业。
Altogether, four of the company's candidate drugs have been granted 12 orphan drug qualifications by the US FDA so far, allowing it to become the enterprise with the largest number of such qualifications domestically, according to the company.
根据该公司，其4款候选药物目前共计获得美国FDA 12项孤儿药资格认定，成为国内拥有该资格数量最多的企业。
The biotech company, one of two federally authorized makers of coronavirus vaccines, said Monday it wants the Food and Drug Administration (FDA) to allow it to add up to 50 percent — five additional doses — of its vaccine in each vial.
这家生物技术公司是两家获得联邦授权生产冠状病毒疫苗的公司之一，周一表示，它希望美国食品和药物管理局(FDA)允许其在每瓶疫苗中多添加多达50%——即额外五剂——的疫苗。
CNBC reported that Moderna had made the request to the FDA on Feb 5.
CNBC报导称，Moderna于2月5日向FDA提出了这一请求。
"Moderna would need to have further discussions with the Food and Drug Administration (FDA) to assure the agency's comfort with this approach before implementing.
Moderna需要与美国食品药品监督管理局（FDA）进行进一步讨论，以确保该机构对其方法感到满意，才会实施这一方案。
"Moderna was the second drugmaker to receive the FDA's emergency-use authorization approval for its coronavirus vaccine in the US after Pfizer BioNTech.
Moderna是继Pfizer-BioNTech之后，第二家获得美国FDA紧急使用授权批准其冠状病毒疫苗的制药公司。
Johnson & Johnson will seek FDA approval for its vaccine soon.
强生公司即将寻求美国食品药品监督管理局（FDA）对其疫苗的批准。
As the United States reported that the number of coronavirus patients in intensive care rose above 20,000 for the first time, there is hope that the Food and Drug Administration (FDA) will give emergency authorization to the Pfizer vaccine on Thursday, clearing the way for its almost-immediate distribution to all 50 states.
就在美国报告新冠患者进入重症监护室的人数首次超过2万人之际，人们寄希望于美国食品药品监督管理局(FDA)将在周四给予辉瑞(Pfizer)疫苗紧急授权，从而为该疫苗几乎立即分发至所有50个州铺平道路。
On Tuesday, the FDA will release its evaluation of the safety and effectiveness data for the Pfizer-BioNTech vaccine.
美国食品药品监督管理局(FDA)将于周二发布对辉瑞-BioNTech疫苗的安全性和有效性数据的评估。
They will debate that data and whether the FDA should clear the vaccine.
他们将讨论这些数据以及FDA是否应该批准这款疫苗。
That will be an open meeting, which includes time for the general public to speak, as part of the FDA's effort to be transparent and convince people to take the vaccine.
这将是一个公开会议，包括让公众发言的时间，这是FDA为了透明度并说服人们接种疫苗所做出的努力。
If the advisory committee votes yes, the FDA is expected to authorize the vaccine within days.
如果咨询委员会投票赞成，预计FDA将在几天内授权使用该疫苗。
Operation Warp Speed, the White House-led initiative to develop and distribute vaccines, has said it plans to begin shipping the vaccine within 24 hours of FDA approval.
由白宫主导的“曲速行动”(Operation Warp Speed)疫苗研发和分发计划表示，打算在获得FDA批准后24小时内开始运输疫苗。
On Dec 15, the FDA will post its view of Moderna's vaccine, in preparation for an advisory committee two days later.
在12月15日，美国食品药品监督管理局(FDA)将发布对Moderna疫苗的看法，为两天后的顾问委员会会议做准备。
According to FDA regulations, the BTD is designed to expedite the development and review process of drugs intended to treat a serious condition when preliminary clinical evidence indicates the drug may result in substantial improvement over available therapies on a clinically significant endpoint.
Products that have obtained BTD will receive closer guidance and various forms of support, including from senior FDA officials, to ensure patients are provided with new treatment options in the shortest amount of time.
The BTD designation will allow it to work with the FDA closely to bring therapy to patients worldwide expeditiously, he said.
In September 2016, the phase-II studies for Lianhuaqingwen were approved by the United States Food and Drug Administration and officially started, marking China's first TCM product to enter the FDA's clinical research.
It was also the first TCM complex compound in the world to enter the FDA's clinical research.
The new policy allows eligible use of qualified products in clinical testing for the novel coronavirus before they have been officially approved or granted emergency use authorization by the FDA.
Previously, some Chinese companies submitted requests to the FDA for such authorization, which permits use of unapproved medical products or unapproved uses of approved medical products in a declared emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions.
The company announced on March 27 that it had received the FDA's formal EUA.
US medical devices company Abbott Laboratories said late Friday it has received emergency use authorization from the US Food and Drug Administration (FDA) for the fastest available point-of-care test for COVID-19.
In order to push quicker results to stem the tide of the COVID-19 outbreak, the FDA approved the first rapid diagnostic test last week, with a detection time of about 45 minutes.
The drug is the first compound discovered in China to have received the FDA's Breakthrough Therapy designation, representing a significant milestone for not only BeiGene but China's pharmaceutical industry.
That makes Conjupri the first innovative drug from the Chinese mainland which has been granted full approval following a standard review by the FDA.
"The FDA approval reflects the international pharmaceutical community's higher recognition of Chinese drug quality," said Shi Lichen, founder of medical consultancy Beijing Dingchen Consultancy.
In November, Chinese biomedicine company BeiGene Ltd's cancer treatment Brukinsa (zanubrutinib) capsules gained Accelerated Approval by the FDA under a Breakthrough Therapy designation to treat Mantle Cell lymphoma.
The treatment was also granted Orphan Drug designation, "which provides incentives to assist and encourage the development of drugs for rare diseases", the FDA said in a statement.
The FDA raised little follow-up inquiries on the clinical data, and also exempted on-site investigation of the company's Chinese factory before approving the drug.
Tyson said in February 2020 it will halt the purchase of hogs raised from American farmers raised with the feed additive ractopamine approved by the US Food and Drug Administration (FDA) but banned in China.
The FDA approved ractopamine in 1999 for use in pigs, cattle and turkeys.
A remedy that receives fast track designation may be eligible for frequent communication with the FDA, priority review, potential accelerated approval according to data and rolling submission, which allows a company to submit completed sections of its Biologic License Application or New Drug Application for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted.
It is the first injectable drugs manufacturer in India that has been approved by the US FDA.
It is the first injectable drugs manufacturer in India to be approved by the US FDA.
Gland Pharma, as one of the world's largest providers of injectable generic medicines, is India's first injectable drugs manufacturer to be approved by the US FDA.
At the heart of the deal is Dendreon's lead product, Provenge, the only cellular immunotherapy approved so far by the US Food and Drug Administration (FDA) for treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
Dendreon, a biotechnology company based in Seattle, a city in Washington state of the US Pacific Northwest, received FDA approval for Provenge in April 2010 and since has reportedly treated more than 20,000 prostate cancer patients with the therapy to curb tumors and prolong life expectancy.
After about a month following the FDA approval of zanubrutinib, Hebei province-based CSPC Pharmaceutical Group Ltd also got a nod from the agency for its Conjupri (levamlodipine maleate) tablets to treat high blood pressure.
在FDA批准zanubrutinib约一个月后，河北的CSPC Pharmaceutical Group Ltd也获得了该机构对其Conjupri（氨氯地平马来酸盐）片剂的批准，用于治疗高血压。
Under the FDA directive, 46 manufacturers in China, including 3M and Creative Concepts' factories in China, and local Chinese companies, will be able to produce and export their respirators to the US.
"We need to do everything we can to increase the availability of critical medical devices … so that healthcare workers on the front lines are better protected and provide the best care to COVID-19 patients," said Stephen M Hahn, FDA commissioner, in a press announcement released by the FDA.
To tackle the shortage in medical supplies, at the end of March, the FDA issued a EUA on imported masks from the European Union, Australia, Brazil, Japan, South Korea and Mexico, excluding China from the list.
Many Chinese companies, including Yichang, Hubei province-based Allmed Medical, Shenzhen, Guangdong province-based Selen Technology, and Hangzhou-based Great Star, said that their masks were currently approved by the FDA and the companies were preparing to ship the products to the US.
A total of 13 ANDA approvals were tentative－the ANDA is ready for approval but the FDA is blocked from approving them because of remaining patents or exclusivities related to the reference listed drug.
The Healthcare Executive Institute, a Beijing-based think tank, also showed an upward trend in the number of generic drug approvals Chinese companies have received from the FDA in recent years.
In November, biomedicine company BeiGene Ltd's cancer treatment Brukinsa (zanubrutinib) capsules gained FDA Accelerated Approval.
About a month later, Conjupri (levoamlodipine maleate) tablets, developed by Hebei province-based CSPC Pharmaceutical Group Ltd, was approved by the FDA for treatment of hypertension.
That made the high blood pressure medicine the first innovative Chinese drug to obtain full approval following a standard review by the FDA.
The orphan drug designation granted by the FDA is beneficial for the continuous development of the combination therapy and the enjoyment of certain policy support in terms of registration and commercialization in the US, including but not limited to tax credits for clinical trial costs, application fee waivers for new drugs and 7 years of market exclusivity without being affected by patent.
The FDA announced on Friday Beijing time its Accelerated Approval of the drug for treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy, based on the overall response rate or how many patients experience a complete or partial shrinkage of their tumors after treatment.
The FDA accepted the application in August, granting it Priority Review.
Previously, the FDA had designated the drug a Breakthrough Therapy in January, a first for cancer therapies developed by Chinese companies as well as new drugs from Chinese mainland overall.
In the US, MCL represents 3 to 10 percent of all non-Hodgkin's lymphoma, and usually responds well to initial treatment, but eventually returns or stops responding as cancer cells continue to grow, according to the FDA announcement.
"The FDA approval for Brukinsa, a chemical drug, highlighted the increased R&D capability of Chinese pharmaceutical companies, and was also of great help for China-developed drugs to reach a higher acceptance rate in both domestic and overseas markets," he said.
"Wang Lai, BeiGene's senior vice-president, said data from the phase-2 clinical trial conducted in China since early 2017 among patients with relapsed or refractory MCL, used in the application accepted by the FDA in August, showed Brukinsa had higher efficacy than the other two similar drugs - AstraZeneca's Calquence (acalabrutinib) and Johnson & Johnson and AbbVi's Imbruvica (ibrutinib).
The FDA said 84 percent of patients had tumor shrinkage with a median duration of response (time between the initial response to therapy and subsequent disease progression or relapse) of 19.5 months, in a single-arm clinical trial of Brukinsa including 86 patients with MCL who received at least one prior treatment.
Since Brukinsa was granted Accelerated Approval, further clinical trials may be required to verify and describe the drug's clinical benefit, according to the FDA.
The drug was also granted Fast Track designation by the FDA for the treatment of patients with WM in July 2018.
That marks the first US FDA approval for a cancer therapy independently developed by a Chinese drug company.
In relapsed lymphoma, the disease reappears or grows again after a period of remission, while in refractory lymphoma, the disease does not respond to treatment or responds only briefly,according to FDA's press announcement.
John V. Oyler, chairman, co-founder and CEO of BeiGene, said in a press release as the company continues to evaluate Brukinsa's potential in other hematologic cancers, it hopes the FDA approval is the first of many for the therapy.
Since Brukinsa was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on a result that is reasonably likely to predict a clinical benefit to patients, further clinical trials may be required to verify and describe Brukinsa's clinical benefit, according to the FDA.
Huang Junhui, secretary of the board of directors at Tinavi, said the CSA certification is equivalent to a prerequisite for applying to the United States Food and Drug Administration (FDA).
"The CSA is a certification body recognized by the FDA.
After this certification, we have the qualifications to apply to the FDA.