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Mingham Ji advises pharmaceutical, biotechnology, and medical device clients on a broad range of regulatory, legislative, and compliance issues before FDA and other regulatory agencies. Ms. Ji has particular experience counseling clients on strategic considerations around engagement with and advocacy before FDA, including through formal dispute resolution proceedings, comments to public dockets, and other submissions to the agency. Her work in this area has spanned both drug development and post-approval issues, including pediatric testing requirements and pediatric exclusivity, risk management and pharmacovigilance, data transparency, and manufacturer communications. Ms. Ji also actively participates in Covington’s multidisciplinary Digital Health Initiative.
- Successful representation of a major pharmaceutical company in formal dispute resolution proceedings regarding eligibility for pediatric exclusivity and the issuance of a complete response letter.
- Outside counsel to PhRMA on FDA regulatory aspects of the FDA Reauthorization Act of 2017 and the 21st Century Cures Act.
- Represented Gilead Sciences in FOIA litigation in Connecticut to prevent release of proprietary information concerning its Hepatitis C drug products.
- Prepared a successful request for FDA’s reconsideration of a rejected proprietary name.
- Represented biopharmaceutical and medical device companies in the preparation of successful trade complaints to FDA regarding violative advertising and promotion materials.
- Conducted internal investigations for multinational pharmaceutical companies to assess complaints relating to data integrity, patient advocacy groups, and the preparation of a pivotal clinical study report and peer-reviewed publication.
- Develop comments to public FDA dockets for industry trade associations and individual companies on a range of FDA regulatory issues including pediatric testing requirements, advertising and promotion, compounding, the drug supply chain, and proprietary and nonproprietary naming.
- Conducted regulatory due diligence on pharmaceutical and medical device companies.
Pro Bono
- Successful representation of a U visa holder in her application for legal permanent residency.
- Provided legal information during walk-in clinics for landlord/tenant issues at Bread for the City and through the DC Bar Pro Bono Program’s Landlord-Tenant Resource Center.
May 5, 2020, Covington Alert
The United States Food and Drug Administration (FDA) recently published a Guidance for Industry, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency (Guidance), to (1) clarify the applicability of the Drug Supply Chain Security Act (DSCSA) to certain distribution activities, and (2) ...
CREATES Act Becomes Law
January 13, 2020, Covington Alert
On December 20, 2019, the President signed the Further Consolidated Appropriations Act, 2020. Effective on that day, Section 610 of Division N of this Act contains provisions previously introduced in various bills as “the Creating and Restoring Equal Access to Equivalent Samples Act” or “CREATES Act.”
FDA Announces Public Workshop on Using Randomized Clinical Trials to Generate Real-World Evidence
June 10, 2019, Covington Digital Health
Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in ...
December 13, 2018, Covington Digital Health
On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”). In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making ...
December 4, 2018, Covington Digital Health
As previewed by Commissioner Gottlieb several months ago (see our earlier post here), FDA published a notice in the Federal Register on November 20, 2018, to propose a new framework for “prescription drug-use-related software.” The Agency defines this digital health category widely as software disseminated by a prescription drug sponsor for use with the ...
December 20, 2017, Covington Alert
On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft ...
November 7, 2017, Covington Alert
On August 18, 2017, President Donald Trump signed into law the FDA Reauthorization Act of 2017 (FDARA). This law, containing nine titles, reauthorizes and amends the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.
August 5, 2016, Covington Digital Health
In a new post on Covington’s InsideMedicalDevices blog, we provide an analysis of FDA’s newly issued final guidance document entitled “General Wellness: Policy for Low Risk Devices.” To read the post, please click here.… Continue Reading
November 17, 2015, Covington Alert
January 23, 2015, Covington E-Alert
April 28, 2014, Covington E-Alert
February 21, 2014, Covington E-Alert
February 5, 2014, Covington E-Alert
FDA Issues Guidance Documents Relating to Liquid Dietary Supplements and Substances Added to Foods
January 16, 2014, Covington E-Alert
December 2, 2013, Covington E-Alert
November 20, 2013, Covington E-Alert
November 12, 2013, Covington E-Alert
11/07/2013
WASHINGTON, DC, November 7, 2013 — Salix Pharmaceuticals, Ltd., and Santarus, Inc. announced today that the companies have entered into a merger agreement where Salix will acquire all of the outstanding stock of Santarus for $32 in cash per share, for a total value of approximately $2.6 billion. Covington & Burling LLP is advising Salix on both the acquisition ...
October 31, 2013, Covington E-Alert
September 24, 2013, Covington E-Alert
August 28, 2013, Covington E-Alert
May 17, 2013, Covington E-Alert
March 6, 2013, Covington E-Alert