People
Amanda Klingler is a partner in the firm’s Washington, D.C. and Chicago offices with more than 10 years of experience advising life science clients. As a partner in the firm's FDA and Life Sciences practice, Amanda advises pharmaceutical, medical device and biotech companies and pharmacies, on a wide range of regulatory matters, enforcement actions, civil litigation, investigations, product liability litigation, and compliance counseling.
Amanda counsels clients on pre- and post-marketing regulatory activities and strategies, including obtaining FDA approval and clearance for medical products. Amanda also regularly advises clients on product labeling, adverse event reporting, product safety issues, recalls/field corrections, import detention, and advertising and promotion issues. She counsels clients on quality system and manufacturing practices for drugs and medical devices and factory inspections, including conducting mock inspections and working closely with and providing advice to clients during the inspection, and provide guidance in responding to FDA investigational observations (FDA-483 forms), and warning letters.
Amanda advises clients during internal and government investigations. She also assists in the negotiation and management of several consent decrees of injunction for pharmaceutical, medical device, food companies and compounding pharmacies.
Amanda works closely with the firm's product liability team and is experienced in handling FDA issues in product liability litigation, including the development of supporting evidence, writing briefs, and preparing expert witnesses to testify.
Amanda also has significant experience and expertise in FDA's regulation of tobacco products.
J.D., Saint Louis University
M.B.A., Loyola University Chicago
B.S., University of Richmond
District of Columbia
Illinois
June 15, 2020
King & Spalding Earns Top-Tier Rankings in Legal 500 United States 2020 Guide
November 3, 2016
King & Spalding Elects 14 New Partners Across Seven Offices
Phillips Morris USA v. FDA, 202 F.Supp. 3d (D.D.C. 2016). Represented one of the plaintiffs in a successful legal challenge to an FDA guidance governing the Substantial Equivalence Review process for tobacco products.
Member of a King & Spalding team serving as national coordinating counsel and trial counsel in product liability litigationinvolving GlaxoSmithKline’s antidepressant Paxil®, including in the Philadelphia Court of Common Pleas Mass Tort Program. Experience includes preparing fact and expert witnesses on FDA issues and briefing motions in limine and Daubertchallenges.
Member of a King & Spalding team representing the manufacturer of FDA-cleared surgical gowns in nationwide litigation concerning the design, labeling, advertising and manufacture of the devices, including: a federal class action trial, the verdict from which is on appeal to the Ninth Circuit; a qui tam suit brought under the Federal False Claims Act in which the court granted defendants' motion to dismiss; and a federal Lanham Act lawsuit concerning allegations of false marketing. Experience includes working extensively with the Company's regulatory expert witness on the FDA-related issues in the litigation, leading the development of the Company's expert report and preparing the witness for his trial testimony.
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January 9, 2023
Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics
December 19, 2022
FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance
October 12, 2022
FDA’s Final Clinical Decision Support Guidance: The Good News and the (Really) Bad News
June 15, 2020
King & Spalding Earns Top-Tier Rankings in Legal 500 United States 2020 Guide
November 3, 2016
King & Spalding Elects 14 New Partners Across Seven Offices
Phillips Morris USA v. FDA, 202 F.Supp. 3d (D.D.C. 2016). Represented one of the plaintiffs in a successful legal challenge to an FDA guidance governing the Substantial Equivalence Review process for tobacco products.
Member of a King & Spalding team serving as national coordinating counsel and trial counsel in product liability litigationinvolving GlaxoSmithKline’s antidepressant Paxil®, including in the Philadelphia Court of Common Pleas Mass Tort Program. Experience includes preparing fact and expert witnesses on FDA issues and briefing motions in limine and Daubertchallenges.
Member of a King & Spalding team representing the manufacturer of FDA-cleared surgical gowns in nationwide litigation concerning the design, labeling, advertising and manufacture of the devices, including: a federal class action trial, the verdict from which is on appeal to the Ninth Circuit; a qui tam suit brought under the Federal False Claims Act in which the court granted defendants' motion to dismiss; and a federal Lanham Act lawsuit concerning allegations of false marketing. Experience includes working extensively with the Company's regulatory expert witness on the FDA-related issues in the litigation, leading the development of the Company's expert report and preparing the witness for his trial testimony.
See more
January 9, 2023
Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics
December 19, 2022
FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance
October 12, 2022
FDA’s Final Clinical Decision Support Guidance: The Good News and the (Really) Bad News
June 15, 2020
King & Spalding Earns Top-Tier Rankings in Legal 500 United States 2020 Guide
November 3, 2016
King & Spalding Elects 14 New Partners Across Seven Offices
J.D., Saint Louis University
M.B.A., Loyola University Chicago
B.S., University of Richmond
District of Columbia
Illinois