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赵芳就各类监管和合规事宜（尤其是生命科学行业的该类事宜）为客户提供咨询。她的执业范围包括就涉及食品、药品、医疗器械、化妆品及其他受监管产品的美国和中国监管事宜提供咨询。她就产品开发和批准、知情同意、监管排他性、标签及促销事宜以及相关的立法倡议事项定期为客户提供咨询。
除了咨询业务外，赵女士还在涉及各类问题的复杂政府执法行动和内部调查中代表客户，这些问题包括临床试验不当行为、数据报告和诚信以及促销事宜。
赵女士的母语是中文，能讲流利的英文。因而尤其擅长就跨境事务为中国企业和在中国从事运营的西方企业客户提供支持。她富有经验，帮助客户梳理中国的贸易和投资法律和政策，制订进入中国市场的最佳策略。
赵女士具备中国法律执业资格，获准在纽约州执业，并且在华盛顿特区以特别法律顾问身份获得执业许可。
食品药品监管事项
- 协助企业和行业协会向美国食品药品管理局和中国国家药品监督管理局（前国家食品药品监督管理局）提交公开意见。
- 就临床试验问题、药品批准和上市专属权为企业提供咨询。
- 就产品促销和标签问题为食品、医药、保健品及化妆品公司提供咨询。
- 为医药和医疗器械公司制订合规政策。
- 就各类问题（如临床试验不当行为、促销和标签及数据完整性）为医药公司进行内部调查。
- 就基因疗法和基因测试问题为企业提供咨询。
- 就交易事项进行监管尽职调查。
白领辩护和调查
- 在多项关于销售和营销行为的内部调查中代表一家大型医疗公司。
- 在针对涉及招聘行为的海外贿赂的政府调查中代表一家大型金融机构。
- 就《反虚假申报法》下引起的问题代表一家大型银行的员工。
国际贸易和投资
- 就世界贸易组织（WTO）规则和自由贸易协议下的外国政府的承诺为公司和企业协会提供咨询。
- 就WTO争议解决程序和中国的电子支付服务法规为一家领先的支付卡协会提供咨询。
- 协助多个客户分析中国政府关于外国投资的审批流程和限制。
公益服务
- 就联邦医疗保险D部分处方药福利为具备双重资格的个人提供协助。
- 就非洲的国内冲突和和平谈判有关的法律问题提供咨询。
- 代表密歇根州的聋哑和听障犯人处理《美国残疾人法案》和宪法权利主张。
成员资格
- 美国律师协会
- 纽约州律师协会
- 注册舞弊审查员协会
- 中美医药专业人士协会
September 30, 2020, Covington Alert
On September 24, 2020, the Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) took major steps toward facilitating the importation of prescription drugs by entities other than the manufacturer, with the stated goal of lowering costs for American consumers.
July 22, 2019
NEW YORK—Covington advised Bayer in a definitive agreement to sell the Dr. Scholl’s™ business to Yellow Wood Partners for a purchase price of $585 million. Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the ...
May 21, 2019
WASHINGTON—Covington advised Merck & Co., Inc., in its definitive agreement under which Merck, through a subsidiary, will acquire privately held Peloton Therapeutics, Inc. in exchange for an upfront payment of $1.05 billion in cash. In addition, Peloton shareholders will be eligible to receive a further $1.15 billion contingent upon successful achievement of ...
Covington Represents Bayer in $550M Sale of Coppertone™
May 13, 2019
NEW YORK—Covington advised Bayer in a definitive agreement to sell its Coppertone™ business to Beiersdorf AG, a provider of skin care products, for $550 million. Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome ...
November 6, 2017, Covington Alert
China has recently announced several initiatives to reform its regulation of drugs and medical devices that could have a significant impact on pharmaceutical and medical device companies doing business in China.
December 7, 2016, Covington Alert
In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to ...
November 2016, Insight Magazine
March 25, 2016, Covington Alert
On March 23, 2016, Novartis AG (“Novartis”) agreed to pay $25 million to settle civil charges with the Securities and Exchange Commission (“SEC”) alleging that it violated the Foreign Corrupt Practices Act (the “FCPA”) by paying bribes to healthcare professionals (“HCPs”) in China from 2009 to 2013 to increase sales. Employees and managers of its two ...
March 2016, Covington Alert
On March 1, 2016, the Securities and Exchange Commission announced an agreement with Qualcomm Incorporated to settle charges that it violated the Foreign Corrupt Practices Act by hiring relatives of Chinese government officials to gain business advantages in the Chinese telecommunications market. The SEC also alleged that Qualcomm provided gifts, travels, and ...
2012, U.S. Chamber of Commerce