Elaine Tseng

King & Spalding LLP

Elaine H. Tseng focuses on regulatory matters in the area of life sciences. A partner in our FDA and Life Sciences practice, Elaine represents medical device, pharmaceutical and other life sciences sector clients in a variety of regulatory strategy, approval, marketing, compliance and enforcement matters.

Elaine primarily represents clients in matters involving the Food and Drug Administration. She provides proactive regulatory strategy and compliance counseling, including in the areas of FDA marketing clearance/approval and exemptions, clinical studies and product development, adverse event reporting, recalls, and other pre- and post-market compliance obligations.

Elaine advises on managing FDA inspections, responding to FDA-483s and warning letters, interacting with FDA on compliance and product review matters, pursuing regulatory appeals and petitions and participating in FDA Advisory Committee deliberations.

Elaine has extensive experience conducting FDA regulatory due diligence assessments in connection with corporate transactions, handling internal investigations involving FDA issues, and conducting audits and assessments of compliance with FDA requirements regarding quality systems/cGMP, clinical trials, and marketing and promotion. She also advises companies on structuring business transactions and ventures to minimize regulatory risk and potential compliance concerns.

Elaine has 20 years of experience with a broad range of FDA matters applicable to medical devices and diagnostic products, including ophthalmic, orthopedic, cardiovascular, and neurovascular devices, in vitrodiagnostic devices and laboratory developed tests, digital health/software products and combination products. She also has substantial experience with FDA regulation of pharmaceuticals, including biopharmaceuticals, and human tissue products.

Previously, Elaine served as Regulatory Counsel at the FDA, where she received the Secretary of Health and Human Services’ Distinguished Service Award and other FDA honors. Elaine has also had in-house experience serving on loan as Corporate Regulatory Counsel at a multinational life sciences company.

EDUCATION:

  • J.D., Harvard University
  • B.A., Cornell University

ADMISSIONS:

  • California
  • District of Columbia
  • Texas

Cost

Rate : $$$

What types of cases Attorney Elaine Tseng & King & Spalding LLP can handle?
King & Spalding LLP can handle cases related to laws concerning Health Care, Mergers & Acquisitions, Government. We manually verify each attorney’s practice areas before approving their profiles and reviews on our website.
Where is King & Spalding LLP located?
King & Spalding LLP is located at 101 Second Street, 575 Mission St #2300, San Francisco, CA 94105, USA. You can reach out to King & Spalding LLP using their phone line +1 415 318 1240. You can also check their website kslaw.com or email them at [email protected].
How much would it cost to hire King & Spalding LLP?
Elaine Tseng lawyer charges are specific to each case. However, they work with contingency fees and its ranges from $$ to $$$. They also provide free consultation [and no obligation quotes] if you are interested to hire.
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King & Spalding LLP
Mission Street 575
San Francisco 94105 CA US
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