RESOURCES

KKB Attorneys Author Chapters in FDLI “Top Cases” Publication
May 11, 2018 | 10:12 AM

The Food and Drug Law Institute recently published the latest annual installment of its popular "top cases" publication, Top Food and Drug Cases, 2017 & Cases to…

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With 55% Market Share and the Creation of a New Verb (“JUULing”), JUUL is Now at the Center of a Firestorm (Vaporstorm?) of Attention
April 30, 2018 | 6:14 PM

By Stacy Ehrlich On April 24, 2018, FDA announced a number of new actions relating to youth access to and use of JUUL products and…

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KKB Partner Stacy Ehrlich Featured in Washington Lawyer Article
January 9, 2018 | 1:42 PM

KKB partner Stacy Ehrlich and her husband Mark Ehrlich were recently featured in the Washington Lawyer cover story “Finding Fulfillment in Life & the Law.” …

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Strong Medicine? After Decades of Diluted Enforcement, FDA Issues Draft Guidance Announcing New Enforcement Policy for Homeopathic Drugs That Takes a Risk-Based Approach
December 19, 2017 | 10:11 AM

by Stacy L. Ehrlich and Celeste D. Wheeler On December 18, 2017, the U.S. Food and Drug Administration (FDA) issued its long-awaited Draft Guidance for…

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New Least Burdensome Guidance
December 14, 2017 | 4:34 PM

By Kinsey S. Reagan FDA today posted new draft guidance The Least Burdensome Provisions: Concept and Principles  (December 15, 2017) addressing the “least burdensome” approach…

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STEM CELL THERAPY AND THE PRACTICE OF MEDICINE
November 17, 2017 | 5:07 PM

By Kinsey S. Reagan Historically, FDA has stated in various contexts that it does not intend to regulate the practice of medicine.  Indeed, the Federal…

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Kleinfeld, Kaplan and Becker, LLP Recognized in “Best Law Firms” Rankings
November 1, 2017 | 2:20 PM

We are pleased to announce that Kleinfeld, Kaplan and Becker, LLP has been recognized by U.S. News & World Report and Best Lawyers in their…

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KKB LAWYERS RECOGNIZED IN 2018 EDITION OF “BEST LAWYERS IN AMERICA”
October 2, 2017 | 4:30 PM

We are proud to announce that Kleinfeld, Kaplan and Becker lawyers have been recognized in the latest edition of “Best Lawyers in America." Information on…

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When A Device Maker Must Submit a 510(k)
September 19, 2017 | 2:13 PM

Bloomberg BNA Publications published an article on September 13, 2017, indicating that FDA expects to meet the statutory timeline of November 8 for release of…

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FDA’s New Plan for Tobacco and Nicotine Regulation
August 3, 2017 | 10:33 AM

By Stacy L. Ehrlich On July 28, 2017, the new FDA Commissioner, Dr. Scott Gottlieb, announced a new comprehensive plan for tobacco and nicotine regulation…

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