Hogan Lovells and Wanda Henry Co. advise Sansure Biotech, Inc. in obtaining FDA Emergency Use Authorization for COVID-19 molecular test kit
Washington D.C., 8 May 2020 – International law firm Hogan Lovells teamed up with regulatory consultant Wanda Henry Co. to advise Sansure Biotech, Inc. in its recent Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a molecular diagnostic test kit for COVID-19.
FDA granted the EUA on May 4, and Sansure reports that its current manufacturing capacity is between 750,000 and 1 million tests per day. This EUA will increase the healthcare system’s capacity to administer clinically validated tests and diagnose COVID-19 cases at a time when additional testing is vital for the management of the current health crisis. Sansure’s test has also received approval in China and the European Union for the diagnosis of COVID-19.
Obtaining authorization for Sansure’s test highlights Hogan Lovells’ capabilities in advising clients on the evolving regulatory landscape and scientific requirements for COVID 19 diagnostic tests. Dr. Young Wang of Wanda Henry Co. noted that “our success in navigating Sansure through FDA’s EUA process reflects good team work, and a good model of scientific and legal collaborating to bring a submission through FDA’s premarket review quickly, and without compromising quality.”
The Hogan Lovells team was led by partner Randy Prebula and senior associate Blake Wilson. The team also included senior director Susan Tiedy-Stevenson and senior associate Dr. Erkang Ai. The Hogan Lovells team worked jointly with Dr. Young Wang at Wanda Henry Co. in advising Sansure.