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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
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 ...
February 22, 2018, Inside Medical Devices
On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug...… ...
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 12, 2016, Inside Medical Devices
The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of ...
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
August 31, 2016, Inside Medical Devices
The China Food and Drug Administration (CFDA) recently released draft rules proposing a new priority review pathway of premarket submissions for certain medical devices with breakthrough technologies (Proposed Rules). This priority pathway builds upon the State Council’s Opinion on Reform of the Drug and Medical Device Approval System (“Document No. 44”), which ...
2016年3月25日, 科文顿电子期刊
2016年3月23日，诺华集团（“诺华”）同意支付2,500万美元就指控其违反美国《反海外腐败法》（“《反海外腐败法》”）的民事起诉与美国证券交易委员会（“证交会”）达成和解。诺华因于2009年至2013年间在中国向医疗专业人员（“医疗专业人员”）行贿以增加其药品销售而被起诉。其两家中国子公司的员工和经理企图利用有同谋关系的第三方代理掩盖不当付款，并将该等付款记录为用于旅行和招待、会议、教育活动和医疗研究的合法支出。该等账簿和记录后来被合并到诺华（在纽约证券交易所上市）的财务报告中。此行为导致违反 《反海外腐败法》下的账簿和记录以及内部会计控制规定。
2016年3月, 科文顿电子期刊
2016年3月1日，美国证券交易委员会宣布与高通公司达成一项协议，就关于其聘用中国政府官员亲属以便在中国电信市场中获得业务优势、从而违反《美国反海外腐败法》的指控达成和解。
2012, U.S. Chamber of Commerce